Algorithm of the process “Working with federal marriage. SOP expiration dates of medicines SOP for dispensing medicines

How to develop and apply SOPs for a nurse, SOPs for the storage of medicines, what documents of operational procedures for medicines must be in health facilities, what rules for the storage and transportation of medicines must be observed?

Who develops and implements standards? What regulatory documents serve as the basis for the development process? What is the structure and sections of the SOP?

You will learn the answers to all these questions by reading the article. You will also find ready-to-download SOPs for taking and storing medicines.

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We have also prepared samples and special collections of standard procedures for you to download.

In fact, these are sets of algorithms and step-by-step instructions that Roszdravnadzor increasingly began to request during inspections.

This requirement has a basis - the Rules of Practice for the Storage and Transportation of Medicinal Products for Medical Use have come into force.

According to this document, all health facilities are required to use the SOP for nurses in their daily activities.

SOPs are standard operating procedures. Today they are an integral part of quality management in any healthcare facility.

In the absence of clear step-by-step instructions, health facility personnel often make professional mistakes, some of which may pose a direct threat to the health and life of the patient.

For example, there are no instructions for preparing a drug solution for intravenous infusion in a healthcare facility.

This leads to the fact that each nurse can use any infusion solution as a solvent, inject the active drug into it in any sequence, set an arbitrary rate of injection of the solution into the patient's vein.

As a result of such inconsistent actions, the risk of developing incompatibility of the components of the dropper, a pyrogen-like reaction, precipitation, etc., increases several times.

In the absence of SOPs, defects also occur at the stages of acceptance and storage of medicines - personnel do not place medicines in storage places in a timely manner, do not install equipment designed to measure air parameters in them, do not observe the temperature regime, do not control the conditions for transporting medicines, etc.

Ready-made collection for a nurse

What SOPs for drugs should be in health facilities

According to the above Rules, the healthcare facility must use SOPs for medicines:

taking medicines;
identification of counterfeit drugs and drugs of poor quality;
detection of expired medicines;
storage of medicines;
maintenance and verification of equipment and measuring instruments;
organization of control over the implementation of the SOP for the storage of medicines in a medical organization.

The circulation of medicines in health facilities is not only acceptance and storage. Therefore, SOPs can be drawn up for all other processes, whether it is prescribing, dispensing drugs to patients, preparing and administering drug solutions, etc.

In order to understand which SOPs for the storage of medicines are needed in a particular medical organization, work in them should be broken down into separate processes.

All possible errors and shortcomings of the staff of the institution should also be calculated:

analyze at what stages of work employees violate the main regulatory requirements for working with medicines;
think about what activities can be carried out so that the performers begin to strictly comply with the requirements of the SOP for the storage of medicines in a medical organization.

After each stage of work has been presented, the causes of errors and violations have been analyzed, and possible consequences have been calculated, it is possible to start developing measures aimed at preventing potential defects in activity.

If it is not possible, develop SOPs yourself, use our templates or a special selection.

Special Collection: All Drug SOPs

Download all SOPs

Who is responsible for developing SOPs

Employees responsible for developing SOPs for a nurse and monitoring their implementation are appointed by order of the chief physician.

As a rule, preference is given to the most experienced and responsible employees, ideally with a higher pharmaceutical education, who are well versed in the intricacies of all processes directly related to the circulation of medicines in health facilities.

According to statistics, in Russia only 50% of pharmacies have pharmacies on their territory or at least one specialist with a pharmaceutical education who could organize work on the circulation of medicines in healthcare facilities.

In the remaining 50%, this work is carried out by the head nurse and head nurses of the hospital departments, based on their own experience.

In the second case, the head and head nurses must receive appropriate training. The heads of the nursing service will need to know the rules for the circulation of medicines in healthcare facilities in Russia, and in particular, knowledge of the rules for the circulation of narcotic drugs and psychotropic substances.

SOP Requirements

A competent SOP of a nurse meets the following requirements:

brevity.
Definition.
Concreteness.

It is good if all the information is presented in the form of diagrams and tables, and the text is used only in cases where it is impossible to represent the algorithm graphically.

How to write and submit an SOP

If you need your own unique SOP, it is important to write it according to the rules. Document Requirements download in the System Chief Nurse and follow the instructions.

It is undesirable to use lengthy theoretical explanations and justifications, otherwise the performer will have to spend time on theory instead of correctly and clearly fulfilling the task of the standard.

All items of the standard operating procedure must be consistent with the requirements of the current regulatory documentation.

At the same time, it is impossible not to take into account the specifics of the institution - this is the only way to bring the safety and efficiency of the health care facility to a new level.

Ready-made standards, which are obtained only when the institution is checked by higher supervisory authorities, are highly undesirable to use. Experience shows that such SOPs are useless in all cases except for external reviews.

In addition, there is always a risk that an experienced inspector will notice discrepancies in the documentation with real activities, then questions cannot be avoided.

What documents are used in the formation of the SOP

Before developing and implementing new SOPs, staff should be informed of the following:

the concept of QMS and the reasons why Russian healthcare facilities are switching to it;
the concept of SOPs, their purpose and objectives.

Talking with the medical staff on this topic is necessary - this will avoid unnecessary questions and rejection of innovations in the workplace.

Part I. "Hat"

This section includes:

full name of the health facility;
the name and number of the standard operating procedure;
The total number of sheets of text and the number of the sheet on which the name of the health facility and information about it is located;
date of entry into force of the document (indicating the initial introduction of the SOP or its revision for any reason);
date of approval of the standard by the chief physician, his signature.

All information contained in the "header" is repeated in abbreviated form on each sheet of the document.

Part 2. Introduction

This section specifies:

the purpose of creating the SOP;
place and conditions of use;
names and positions of employees appointed by the chief physician for the development of the bottom document.

Part 3. Main part

Here are listed all the operations that must be strictly observed by medical personnel.

This should also include what to do in the event of an emergency.

Legal documentation

The nurse's SOP should include only those documents that govern the process described in the standard. The list of documents can be given both at the beginning and at the end.

SOP allocation table

In the SOP distribution table, you can indicate the departments and responsible persons who received this standard (original and numbered copies) and pledged to strictly execute it.

SOPs can be developed in-house or outsourced. The third option for developing SOPs is to adapt ready-made SOPs to the needs of your healthcare facility.

Before writing an SOP for any procedure, instruct the responsible employees to study the standards, GOSTs, guidelines, “good practices”.

This document obliges to ensure the implementation of a set of measures aimed at creating a system for ensuring the quality of storage and transportation of medicines. What this system is and how it should be implemented in a pharmacy organization, she told NataliaZolotareva, Ph.D., Associate Professor of the Department of Management and Economics of Pharmacy, St. Petersburg State Chemical Pharmaceutical Academy.

In accordance with the current legislation, namely the Federal Law "On the Circulation of Medicines", pharmaceutical activities include wholesale and retail trade in medicines, storage , transportation, dispensing and manufacturing of medicines (PM). In Decree of the Government of the Russian Federation of December 22, 2011 No. 1081, for the first time, a set of works and services was specified by law, which includes pharmaceutical activities. Also, in accordance with the current regulation on licensing pharmaceutical activities, a certain set of requirements and conditions has been established that pharmaceutical organizations must comply with without fail when applying for a license or having one and carrying out relevant activities.

I would like to draw attention to one of the subparagraphs of paragraph 5 concerning licensing requirements and conditions for the storage of drugs in a pharmacy organization. Subparagraph h states that a licensee storing drugs for medical use must comply with the relevant storage rules. This subparagraph is included in the range of license requirements and conditions, the violation of which is considered gross and liability for which is established by applicable law.

TERMINOLOGY

One of the articles of the State Pharmacopoeia XII edition is separately devoted to the process of storing drugs, and it clearly states that this is a separate process that is an integral part of the circulation of drugs and is associated with the storage of drugs until they are used within the established expiration date.

The process of storing medicines involves solving several global problems, incl. and in connection with the introduction of new regulatory documents, therefore, organizing the storage process, it is necessary to create a quality assurance system that will allow the storage process to be carried out in accordance with the requirements of regulatory documents. It is also necessary, when organizing storage, to ensure the physical safety of the goods. And an important point is related to the fact that drugs are a product, most of which require special storage conditions. In this regard, another important task arises - the creation of conditions that ensure the stability of those properties of the goods that are declared by the manufacturer. In order to solve these problems, three areas of activity of those who are directly involved in the storage process emerge.

First- taking into account the requirements of new regulatory documents, develop a quality assurance system, and it involves a number of instructions and provisions, the so-called SOPs, and the documents provide a specific list of standard procedures that need to be developed at the organization level and approved.

Second- provide the storage process with the necessary premises, equipment that must meet the requirements established for them.

Third - creation of the necessary storage mode and organization of the placement of goods during storage (systematization).

LEGISLATION ON THE PROCESS OF STORAGE OF MEDICINES

Let's start with the regulatory framework of federal significance, with the Decree of the Government of the Russian Federation No. 1148 of December 31, 2009 "On the procedure for storing narcotic drugs and psychotropic substances." This document has been repeatedly supplemented and updated.

Of course, attention is drawn to the "Rules of good practice for the storage and transportation of drugs for medical use", approved by order of the Ministry of Health of Russia dated August 31, 2016 No. 646n and entered into force on March 1, 2017.

Also among the documents is the current order of the Ministry of Health of Russia dated August 23, 2010 No. 706n "On approval of the rules for storing medicines"; order of the Ministry of Health of July 24, 2015 No. 484n concerning the organization of storage and the creation of special regimes for narcotic drugs and psychotropic substances; the order of transportation and storage of immunobiological drugs of 2016 is determined by the relevant resolution of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19; order of the Ministry of Health of the Russian Federation dated October 21, 1997 No. 309 approves the instructions for the sanitary regime of pharmacy organizations (it received a second life in connection with the entry into force of the Rules of Good Pharmacy Practice, where special attention is paid to the procedure for cleaning premises, for which appropriate standard procedures should be developed). How to write them? The answer is obvious: based on the requirements of regulatory documents. In addition to Order No. 309, it is hardly possible to name instructions at the level of the Ministry of Health of the Russian Federation that would answer the question of how the sanitary regime should be properly organized.

Regulatory documents related to pharmacy organizations, wholesalers, and healthcare institutions are:

order of the Ministry of Health and Social Development of Russia dated 09.01.07 No. 2 "On approval of the norms of natural loss during storage of medicines in pharmacy organizations, drug wholesalers and healthcare institutions". This document is relevant only for those organizations that are related to substances. Natural loss implies the presence of the corresponding type of work;
order of the Ministry of Health of Russia dated 11/13/96 No. 377 "On approval of instructions for organizing storage in pharmacy organizations of various groups of drugs and medical devices";
order of the Ministry of Health of Russia dated July 16, 1997 No. 214 of Russia "On quality control of medicines manufactured in pharmacies";
general pharmacopoeial article OFS.1.1.0010.15 "On the storage of medicines".

QUALITY ASSURANCE SYSTEM

Let's start with document No. 646n, which entered into force on March 1, 2017. It contains certain innovations that require clarification. This document applies to a fairly large number of participants in the field of drug circulation. The first paragraph of the document says that the executors of this order are manufacturers, drug wholesalers, pharmacy organizations, individual entrepreneurs engaged in pharmaceutical activities, as well as medical organizations, including FAPs, outpatient clinics, centers of various kinds located in those settlements. points where there are no pharmacy organizations, and which are endowed with FZ-61 in 2010 with part of the authority to carry out a separate type of work and services of pharmaceutical activities.

The second section of this document attracts special attention - this is a system for ensuring the quality of storage and transportation of medicines. Speaking about the organization of storage, I would like to start with the requirements that are imposed today in terms of creating a quality assurance system.

The document clearly states that this is a wide range of responsibilities. The quality assurance system requires a very serious resource in terms of time, money, and personnel, because SOPs will have to be written by process owners, i.e. those who directly carry out certain processes of storing, receiving, dispensing medicines. At the same time, no one relieves the manager of responsibility for organizing a whole range of measures, which will maintain the appropriate quality of drugs in connection with their storage.

The quality assurance system is a set of measures that is associated with the development and approval of a number of issues. First, you must clearly state in a separate local regulatory act of the organization how you work with suppliers, according to what criteria they are selected, since this is an outpost of the procurement process and the related receipt and storage of medicines.

Order No. 646n says that standard operating procedures, the so-called SOPs, should be developed for the process of receiving, transporting, and placing medicines. This can either be a document that sets out all of these processes as a whole, or a document that can describe individual standard operating procedures. As you wish. Today, regulatory documents do not describe in any way whether you should issue everything together or separately. The forms of documents in which you record the progress of the processes should be prescribed. You must record all this in your instructions and provisions related to the drug storage process. It should also be clearly spelled out how counterfeit, substandard, counterfeit drugs are detected. Maintenance and checks of measuring instruments and equipment that should be in the storage of medicines are carried out, and it is important how to monitor compliance with standard operating procedures. They are not created in order to write and forget once on paper. There is a certain positive moment in the standard operating procedures. This is a document that, to a certain extent, formalizes the procedure for personnel actions, excluding the subjective factor, errors in the reception, transportation, placement and any other process related to pharmaceutical activities. The regulatory document suggests that standard operating procedures should live the life of a pharmacy organization, should change when there are objective reasons. The reason for making a change in the standard operating procedure may be control activities, internal audits, which should also be clearly spelled out at the organization level. All activities related to the functioning of quality assurance, storage and transportation systems are carried out by a responsible person - a quality officer. All processes must be systematized, documented, familiarized with employees and calmly work according to the developed documents.

SOP - STANDARD OPERATING PROCEDURE

SOP is an algorithm of certain actions for different processes, a document that describes step by step the set of actions that an employee of a pharmacy organization must carry out in order to perform a particular procedure.

In terms of the type of standard operating procedures, there are two important regulatory documents - orders No. 646n and No. 647n. They specify verbatim what specific standard operating procedures are to be developed. But there is no clear classification of SOPs, and each organization systematizes them independently. Large companies, as a rule, allocate everything related to equipment, its verification into separate groups of SOPs, SOPs related to cleaning the premises, risk management, and even SOPs for managing SOPs can be allocated as a separate block. This is the document that will describe who is involved in the development of documents, what kind of documents they participate in, how many copies and copies of these documents, where they will be stored, updated and agreed upon. This is a huge piece of work. Therefore, where there are many standard operating procedures, SOPs are needed to manage SOPs.

SOPs are not the only document that forms the quality system documentation. The main document is the quality manual. Order No. 647n says that such a document should be developed, it provides the tactics of the organization in terms of ensuring the quality of the relevant goods, meeting consumer requirements in the implementation and implementation of a particular type of work or service. The documents of the second level are SOPs, which indicate who, what, when, with the help of what resources carries out job descriptions, etc. (including quality records).

Unfortunately, today there are no clear instructions on how this document should be drawn up, in what format. But, one way or another, when describing the process, you must answer at least a few questions: who carries out this process, with what equipment, what resources are involved, what procedures are used, what methods and how this process can be evaluated or measured . There is nothing complicated, it is only necessary to systematize a huge amount of documents and present them in a logical sequence.

Process description scheme, i.e. A standard operating procedure should typically include the following sections: the purpose of the process, its scope, responsibilities, references to the documents you used to develop it, terminology if necessary, and a key section - the process flow itself and quality records.

Order No. 646n requires the development of a number of standard operating procedures, incl. to receive goods.

EXAMPLE OF SOP - RECEPTION OF MEDICINES BY A PHARMACY ORGANIZATION

It is good practice to start the SOP with an SOP identifier, which should indicate the type of document or number the procedures. According to the normative documents of the quality assurance system, you must continuously improve, take corrective and preventive measures and actions. How do you prove that they were carried out? Including changing the standard operating procedure. The second improved version will be reflected in the identifier. This will show the reviewer that your versions are working and they are changing.

Preparatory measures - preparation of places for the receipt of drugs (refrigeration equipment, safes, cabinets, racks, depending on the type of drugs).
Unloading. Upon receipt of drugs, the correctness of transportation is checked.
Placement of drugs. Narcotic drugs require instant transfer to safes and metal cabinets. At the next stage, the person responsible for receiving checks the accompanying documents, then the consignment note is filled in, the acceptance stamp is put, the documents are transferred to the supplier.
Acceptance control. There are two possible scenarios for the development of events: if everything suits the acceptance control or there are questions in terms of quality and quantity during acceptance, and then certain actions are required on the part of the responsible person. In the first case, if you agree with the delivery, a corresponding entry is made in the accompanying documents (invoice, acceptance stamp, pharmacy seal, full name and signature of the responsible person on the approval protocol) and then the process of registering the received goods in the acceptance control log, the form of which is not determined by the current regulations. It is determined by the head of the pharmacy organization. If subject-quantitative medications are received, entries are made in the appropriate journal.

In the second case, if you do not agree, either in terms of quantity or quality of medicines. In this case, the responsible officer draws up a letter of claim, the commission, on the basis of it, draws up an act on identifying discrepancies in quantity and quality upon acceptance of drugs. Such goods must be placed in a quarantine zone until the circumstances are clarified. Completion of the SOP - if the acceptance control does not reveal non-compliance with the quality requirements, the preparations should be placed at the storage sites, taking into account a separate SOP. Next, we deal with the reusable returnable packaging and transfer it to the designated area, prescribe responsibility. The document should include such positions as how and who developed (direct participant and controller), who agreed. The manager approves the standard procedure.

The golden rule of GMP: what is not documented does not exist.

REQUIREMENTS FOR PREMISES

Premises requirements are very important in terms of storage organization. They are determined by two regulatory documents: orders of the Ministry of Health No. 706n and No. 646n. The device, composition, operation and equipment of premises for storing medicines must correspond to the volume and type of work performed and, of course, ensure the safety of medicines. For pharmacy organizations, there are no requirements for the composition of premises, areas, unlike manufacturers and wholesalers. Only wet cleaning of the premises is allowed, and in accordance with the requirements of Order No. 646n, the cleaning procedure must be recorded in the SOP.

Traditionally, storage rooms should be provided with equipment in the form of racks, cabinets, pallets, and they should be identified and marked. Storage rooms are fixed and must be maintained at a certain temperature and humidity. The premises are equipped with devices for recording temperature and humidity parameters. Instruments must be maintained in good condition. A separate document should record the process of putting the equipment into operation, its verification. This may be a separate SOP.

Order No. 706n speaks of the need to account for drugs with a limited shelf life.

A pharmacy organization must have quarantine zones: one for drugs for which a decision has been made to suspend sales, another for counterfeit products, drugs with an expired shelf life, and another zone for other pharmacy products. Each pharmacological group of drugs is stored in accordance with its specifics: for example, drugs subject to subject-quantitative accounting require separate storage, etc.

Based on materials from an online seminar organized by the St. Petersburg Union of Doctors

1 Purpose

This standard operating procedure (SOP) describes the sequential steps (sub-processes) for receiving goods from a supplier:
- Checking documents for incoming goods.
- Unloading goods from the vehicle to the goods acceptance area.
- Checking certificates/declarations.
- Acceptance of goods in terms of quantity and quality. Entering data into the system.
- Actions with substandard goods.
- Goods item acceptance confirmation.
- Preparing goods for storage.
- Posting invoices and quoting goods

Application No. 1

Requirements for the preparation of financial documents

Title of the document	Mandatory document requirements
Packing list	Original document (Unified Form No. TORG-12)
	There are no corrections in the document






	Original seals of the organization - consignor
Invoice	original document
	Missing fixes
	Full name of the shipper organization (details)
	Legal address of the consignor organization
	TIN and checkpoint of the consignor
	Full name of the consignee organization (address, details)
	Legal address of the organization-consignee
	TIN and KPP of the consignee
	Number and date of issue of the document
	Product name, quantity
	Price and total amount of goods issue (VAT included)
	Country of origin
	GTD number (for deliveries if the country of origin is NOT Russia)
	Original signatures of the head and chief accountant with their transcript (if the position is provided for in the organization)

Application №2

Form of the Act on the establishment of discrepancies in quantity and quality

Act on the establishment of discrepancies in quantity and quality

upon receipt of goods (Form AP-2)

Form No. AP-2

Approved by the Ministry of Health of the USSR 08.01.88 No. 14

"APPROVED General director.

Act No. _______ dated ______________ 2011

on the established discrepancy in quantity and quality upon acceptance of goods

Commission consisting of: chairman of the commission

Commission members:

received the goods and installed:

Shipper's name and address: __________________________________
Supplier invoice _____________________________
Contract No. _______________ dated __________________ for the supply of products.
Cargo sent G. in a container, wagon, motor van No. ________________ receipt No. ________________ from the station _______________ in the amount of __ places with a gross weight of ______________ kg.
The cargo arrived at the station _____________________ "___" ___________ 2011, redeemed "____" ______________. and delivered to the consignee's warehouse "__" ________ 2011. in the amount of ______________) places.
The commercial act was not drawn up, it was drawn up under No. __________ dated _______________ and is attached to the act _________________________________________________________________________
The container (van) was opened Omsk, pharmacy warehouse "___" ___________ 2011. at ___h.___min. In the presence of the commission of the reception department. The condition of the seals and the content of the impression __________________________________________________________________________________________

Continuation of Appendix No. 2

The representative of the consignor (manufacturer) was called by telephone message (telegram) No. __________ dated "____" ______________
Conditions of storage of goods prior to acceptance: _________________________________________________________________________
The load was overweight not outweighed. Its gross weight is __________________________________________________________
Detailed description of goods and containers according to external inspection:
State of outdoor marking of places:
The way to determine the shortage, whether the missing products could fit: ____
Determination of the quantity of goods was carried out by serviceable weight measuring instruments, checked in the prescribed manner.
The members of the commission were familiarized with the instructions on the procedure for accepting consumer goods in terms of quantity and quality, established by the resolutions of the State Arbitration Court under the Council of Ministers of the USSR.
The results of admission (the amount is indicated at the acquisition prices):

No. p / p

Name of product

Unit rev.

quantity

According to the documents

supplier

shortage

The battle

Marriage

surplus

price

sum

quantity

sum

quantity

sum

count

quantity

For the rest, listed in the supplier's invoice, there are no discrepancies in quantity and quality.

A detailed description of the defects (the nature of the shortage, surplus, marriage, battle) and the opinion of the commission on the reasons for their formation:
Conclusion of the commission: ________________________________________________________________________________________________________________

Receiver: __________________

Commission Chairman: ______

Commission members: _____________

Representative of the Supplier __________________ Document No. ____________________________________________

(passport, driving license.)

Appendix No. 3 (mandatory)

Instructions for filling out the Act (Form AP-2)

An act on establishing discrepancies in quantity and quality upon acceptance of goods (hereinafter referred to as the Act) is drawn up:

- upon receipt of goods at the warehouse from the supplier.

The act is drawn up by the selection committee separately for each consignment of goods (invoice) in cases where a shortage, fight, marriage, and damage to goods is established. The commission must include Warehouse. The composition of the commission is approved by an order adopted by the Company.

The act is approved by the General Director

To participate in the acceptance of goods and draw up an act, if possible, a representative of the supplier or carrier is invited, whose data are entered in the act.

All details of the act must be filled out clearly and legibly, as it is a document on the basis of which claims are made and the debt to the supplier is reduced.

The act is drawn up in 4 copies:

The 1st copy is given to the supplier with a set of supplier's documents for the imported goods;

— the 2nd copy is transferred to the Check-In Group of the Accounting and Storage Department with a set of documents of the Company for the imported goods for posting in the accounting system and subsequent transfer to the accounting department;

– the 3rd copy of the act is sent to the Claims Manager of the Logistics Department no later than 1 (one) business day from the date of preparation;

— The 4th copy (original) remains in the Goods Receiving Department.

The act consists of two parts:

General information;
The results of receiving goods.

When filling Admission results(paragraph 16) the following order should be observed:

This section includes only those items for which there are discrepancies in quantity and quality.

Column 1 - number in order

Column 2 - the name of the goods in accordance with the invoice, the series indicated in the shipping documents is written (in the absence of information in the invoice, we put the series indicated on the package).

Column 3 - unit of measurement (pieces, packages, bottles, etc.)

Column 4 - the amount of goods on the invoice

Column 7, 13 - is filled in according to the quantity actually received, in case of re-sorting, two entries are made in the act - separately for shortages and surpluses.

Column 9 - the number of broken packages (units) of goods in glass containers.

Column 11 - the number of packages with mechanical damage, smudges, etc.

AT The conclusion of the commission the claim for shortage, surplus, damage and marriage of goods is described in detail. It also indicates the location of surplus and defective goods (returned to the supplier or located in the receiving department).

The act is signed by the Receiver, who accepted the goods and revealed the facts of the violation.

Members of the commission confirm the Act with their signatures.

The supplier's representative signs the Act indicating the number of the document confirming his identity (passport or driver's license).

The act is certified by the blue seal of the Society.

Application No. 4

Remaining shelf life requirements

Application No. 5


Vehicle parking pass
Date, time of issuance of the pass:
Car model:
Register sign:
Trailer registration plate:
Driver (full name):
Phone number:
Client:
Type of work (loading / unloading):
gate number:
Invoice No.:
Number of places (Pal/Kor/Piece):
No. of seals according to the document:
Receiver:
Pass issued by:
M.P.
The vehicle was installed by:
<< ______ >> ________________201__ ______ hour ______ minutes
Temperature inside the vehicle, ºС
No. of seals in fact:			receiver
Number of unloaded pallets/places:			receiver
Condition of returnable packaging (pal)

Here you can purchase samples of documents of the quality management system for pharmaceutical activities and other necessary local acts for both retail and wholesale pharmaceutical organizations.

You can order documents for wholesale pharmaceutical organizations (pharmacy warehouses) by clicking on this.

You can order documents for the pharmacy departments of healthcare facilities by clicking on this

Acquisition of documents for retail pharmacy organizations

January 9, 2017 The Ministry of Justice of Russia registered Order of the Ministry of Health of Russia No. 647n dated August 31, 2016 "On Approval of the Rules of Good Pharmacy Practice for Medicinal Products for Medical Use". The Rules of Good Pharmacy Practice of Medicinal Products for Medical Use establish requirements for retail trade by pharmacy organizations and individual entrepreneurs, medical organizations that have the appropriate license and their separate subdivisions. The order comes into force on March 1, 2017.

On September 22, 2017, approved by the Order of the Ministry of Health of the Russian Federation dated July 11, 2017 N 403n "Rules for the release of drugs for medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities" came into force . The order was officially published on September 11 and, accordingly, entered into force 10 days after the date of publication - September 22, 2017. Approved by the Order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 N 785 "Procedure for the release of medicines" from September 22, 2017, became invalid. The documents we propose take into account these new rules.

You can check the availability and identify the need for the development of documentary acts and SOPs by your pharmacy organization based onfrom checklists approvedOrder of Roszdravnadzor No. 9438 dated November 9, 2017"On approval of the forms of checklists (lists of checklists) used by the Federal Service for Surveillance in Healthcare and its territorial bodies during scheduled inspections in the exercise of federal state supervision in the field of circulation of medicines"(DOWNLOAD);

Here you can purchase samples of orders for the organization of pharmaceutical activities and other necessary local acts in a single package, which we send to you by mail. This package includes the necessary local documents of the pharmacy organization, which are required by the inspection authorities and which must be accepted in any such organization. This package also includes documents on good pharmacy practice: SOPs, orders, instructions.The cost is only 4000 rubles, taking into account the discount.

You can buy a package of documents by contacting us by phone, e-mail, or directly through the payment system. Also, you can pay for a package of documents using the service from yandex at the end of the page. A package of documents will be sent to you by mail within 12 hours from the moment of payment, documents are usually sent within 10-15 minutes.

If necessary, it is possible to conclude an agreement for the provision of legal services with the issuance of an invoice, the signing of an act for the provision of services, etc. for legal entities and individual entrepreneurs.

Some sample documents can be downloaded right now. The complete package includes:

Orders:

Order on the appointment of a person responsible for organizing classes for the study of regulatory documentation

Order on the appointment of a person responsible for accounting for disinfectants, carrying out decontamination

Order on keeping records of medicines with a limited shelf life

Order on the appointment of a commission for the acceptance of goods

Order on the appointment of a cashier-operator responsible for maintaining the journal

Order on the appointment of a person responsible for the minimum assortment

Order on the appointment of a person responsible for the availability, updating and provision of information

Order on the appointment of a person responsible for organizing primary and periodic medical examinations of personnel

Order on the appointment of a person responsible for labor protection and electrical safety

Order on the appointment of a person responsible for fire safety

Order on the appointment of a person responsible for providing information on the prohibition of the sale

Order on the appointment of a person responsible for compliance with the procedure for dispensing medicines by pharmacy employees

Order on the appointment of a person responsible for temperature and humidity

Order on the appointment of a person responsible for safety

Order on the appointment of a person responsible for pricing

Order on the appointment of responsible persons for the timing and compliance with the requirements to prohibit the sale of unusable drugs

Order on the appointment of a quality representative

Order on the procedure for writing off (destruction) of substandard medicines

Order on the method of systematizing the storage of medicines adopted in the organization

Order on the establishment of a commission for internal audits

Order on Restrictions on Medical and Pharmaceutical Workers

Order on the person responsible for the reception, storage and accounting of potent drugs that are subject to quantitative accounting

OTC Dispensation Liability Order

Order on approval of the schedule of sanitary days

First aid order.

Magazines:

Journal of periodic registration of temperature inside the refrigeration equipment option;

Journal of periodic registration of temperature inside the refrigeration equipment;

Introductory briefing registration log;

Journal of registration of briefing at the workplace;

Electrical safety briefing register;

Journal of registration of work instructions and sop;

Log of registration of operations in which the number of precursors changes;

Journal of registration of sanitary days;

Journal of registration of orders in a pharmacy;

Journal of registration of the results of acceptance control option;

Journal of registration of the results of acceptance control;

Check log;

Fire safety briefing register;

Journal of registration of transactions related to the turnover of PCU;

Journal of accounting of laboratory and packing works for the production of pharmacies;

Journal of transactions related to the circulation of medicines for medical use;

Journal of daily registration of temperature and humidity parameters in the premises;

Journal on the provision of drugs included in the mine range;

Journal of registration of incorrectly written prescriptions;

Defect accounting log;

Journal of accounting of laboratory and packing works for non-manufactured pharmacies;

Accounting for the receipt and consumption of vaccines;

Journal of information work with medical organizations on the procedure for providing certain categories of citizens with medicines;

Journal of registration on issues of ensuring the safety of the quality of immunobiological;

Registration of acts for the movement of goods to specially designated areas (quarantine);

Journal of registration of medical examinations;

Journal of accounting for the movement of work books;

PPE accounting journal;

Temperature registration log in refrigeration equipment in accordance with sp 3.3.2.3332-16

Movement log ilp.

Standard operating procedures:

Instructions for organizing the storage of medicines in a pharmacy;

Instructions for dispensing prescription drugs;

The procedure for the sale of medicines without a doctor's prescription;

Instructions on the rules for washing and disinfecting the hands of personnel;

Instructions on compliance with personal hygiene rules by staff;

Instructions for cleaning the premises and processing equipment of the pharmacy;

Organization of medical examinations in a pharmacy organization;

The procedure for storing, dispensing and accounting for potassium permanganate in a pharmacy;

The procedure for dispensing medicinal products containing codeine or its salts;

The order of measurement and registration of climatic parameters;

The procedure for developing work instructions (ri) and sop;

Instructions for the acceptance of drugs and taa;

Instructions for working with rejection;

The procedure for the selection and evaluation of suppliers of pharmaceutical products;

Procedure for consideration of complaints and proposals of buyers;

Instructions for cleaning up spilled and spilled drugs;

The procedure for organizing work with information on the suspension of sales, withdrawal from circulation of medicines, medical devices;

The procedure for the implementation of internal control and analysis of its effectiveness;

The procedure for the implementation of pharmacovigilance in a pharmacy organization;

The procedure for organizing work on accounting for medicines with a limited shelf life;

Instructions for pricing in a pharmacy organization;

Management of access to the premises of the organization;

The procedure and safety requirements for handling waste of the 1st hazard class;

The procedure for minimizing the risk of contamination of medicinal products;

The procedure for the transportation of medicines;

Instructions for the safe handling of medical waste;

Documents on the regulation of good pharmacy practice in a pharmacy:

Order on compliance with the rules of proper pharmacy practice;

Pharmacy quality manual;

Due Quality Commissioner's Instruction;

SOP approval order;

Act of internal audit;

Schedule of classes for professional development. employees

Onboarding program for new employees.

Job descriptions and other documents:

Job description of the head of the pharmacy;

Job description of a nurse;

Job description of a pharmacist;

Inner order rules;

Production control program;

Employment contract with a pharmacist;

Employment contract with the manager;

Regulation on combating corruption;

Order on Approval of Anti-Corruption Regulations;

Anti-terrorist security of the facility;

Magazines on health and safety, job responsibilities and instructions for labor protection and other documents. In total, about two hundred forms of documents.

It will be possible to receive all documents in doc or docx format only after payment. Payment is made through