Decree of the Ministry of Health of the Czech Republic No. 284 / 1990 Coll.
Decree of the Ministry of Health of the Czech Republic on good manufacturing practice, quality management of medicinal products and medical and packaging equipment
Valid
Effective from 01.09.1990
Contents
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284
DECLARATION
Ministry of Health of the Czech Republic
of 5 July 1990
on good manufacturing practice, quality management of medicinal products for human use and medical and packaging equipment
The Ministry of Health of the Czech Republic provides pursuant to § 70 (1) (b) and (c) with respect to § 62 (2) and § 63 of Act No. 20 / 1966 Coll., on the care of the health of the people:
INTRODUCTORY PROVISIONS
Purpose of the Order
This Decree lays down, in accordance with the latest knowledge of science and technology and health care needs, conditions of good manufacturing practice, quality management of medicinal products for human use and medical and packaging equipment ("good manufacturing practice ') .1)
Scope
This decree applies to the authorities and organisations which manufacture, prepare, package, control, distribute, store and store medicinal products and diagnostics, auxiliary substances, medical and packaging technics2) (hereinafter referred to as "organisations') and to the staff of these authorities and organisations.
Basic concepts
(1) The starting substance is any substance used in the production, regardless of whether it is present in the final product.
(2) Intermediate product means any material or mixture of materials which must be subjected to further manufacturing activities.
(3) Unfilled product means any product which has undergone all stages of processing with the exception of disassembly and packaging.
(4) Contamination is microbiological, chemical and mechanical contamination of the parent substance, intermediate product, unfilled or finished product.
(5) Validation is an activity demonstrating that the material, process, process, activity, equipment or mechanism used in production or control achieves and will achieve the desired and intended results.
(6) Lot means the quantity of products prepared at the same time in a single production cycle; the essential characteristic of the lot is its homogeneity.
(7) The concentrated preparation of pharmaceuticals and diagnostics (hereinafter referred to as "pharmaceuticals") is a mass preparation in batches carried out in pharmacy facilities.
(8) Quarantine means, for the purposes of this Ordinance, the status of starting substances, intermediate products or products stored separately, identified or, where appropriate, stored in computer memory in such a way as to show that they are at the control stage and are awaiting a decision on their suitability for processing or distribution.
(9) Stability is the property of the parent substance, intermediate product or finished product to retain within the permissible limits for a certain period and under the specified conditions of storage of the same quality characteristics as the parent substance, intermediate product or finished product at the time of manufacture.
(10) The test shall mean a certificate of a controlled medicinal product, an auxiliary substance, medical or packaging equipment indicating a reference to the test report by which the medicinal product has been released as satisfactory.
(11) For the purposes of this decree, medical devices shall mean articles, aids and tools intended for the body or body of a human being, for the treatment of humans, contraception or diagnosis.
(12) Diagnostics are for the purposes of this decree: substances administered to humans for diagnosis of disease and laboratory diagnostics.
(13) Sanitary zones are spaces of varying degrees of purity with defined air treatment, with prescribed sanitary and hygienic procedures.
(14) The means of packaging are articles and aids made of various materials that come into direct contact with the medicine and serve for its storage and protection against external effects.
(15) Technological reglement is a set of rules determining the method of production and the scope of its control for the standard batch size in order to ensure the required standard quality and production management.
(16) Continuous production checks are checks and measurements carried out during production, including adjustment, to ensure that the resulting product complies with the relevant standard.
GENERAL CONDITIONS
CORRECT INDUSTRY PRACTICE IN GROSS PRODUCTION
Workers
(1) Only workers whose qualifications, moral responsibility and health status guarantee compliance with the requirements laid down in those activities may work in the manufacture, control, filling, packaging, storage, distribution, handling of raw materials, intermediate products, unfilled products, packaging and finished products.
(2) The organisation is obliged to set up a senior producer responsible for the production and a senior officer responsible for quality management and to exclude any interference in their competence. The function of the manager responsible for production shall be incompatible with that of the manager responsible for quality management.
(1) The executive responsible for production is responsible for the quality of products, for the production area, for the condition of equipment and equipment, for the production activities, for carrying out the continuous production control and for the production documentation.
(2) The manager responsible for quality management shall be responsible for quality management and control, for the condition of the instruments and equipment, for the preparation and maintenance of the control documentation and for compliance with the prescribed control procedures.
(3) The production manager and the quality management manager shall jointly develop a quality control system, in particular an ongoing production control.
(1) Leaders responsible for production up to the position of master and managers responsible for quality management must have:
(a) completed higher education in pharmaceutical or other higher education in the relevant field with the required additional specialisation established by the Ministry of Health of the Czech Republic (hereinafter referred to as "the Ministry") .3)
(b) at least three years of experience in production or control.
(2) For other professional and production managers, the organisation is entitled to require the prescribed training to be completed only in cases where the worker fulfils the training in a direction which corresponds to his or her activities.
(3) The organisation is required to ensure continued training and training of workers4) in terms of good manufacturing practice according to their expertise and to verify the level of knowledge and skills acquired.
The organisation is required to ensure that workers with communicable diseases, with open injuries on the exposed surface of the body and germ carriers do not work in the manufacture of medicines and medical and packaging equipment and must ensure that they do not stay in these workplaces.
Space
(1) Medicinal products, excipients, medical and packaging equipment are produced and stored in rooms which are appropriately adapted to the design solution, size, number, layout and equipment and enable the manufacture, storage, control, packaging and distribution of medicinal products, auxiliary substances, medical and packaging equipment under this Decree.
(2) The organisation is required to ensure the design, construction and location of buildings so as to prevent contamination from the outside. Effective measures shall be taken in production and storage areas to prevent confusion, contamination, unauthorised entry, insect penetration, animals and waste accumulation. Production and storage spaces must be divided into hygienic zones. 2)
(3) Floors, walls and ceilings must be impermeable, smooth, without outlets, cracks and clasps, washable and resistant to disinfectants, as required for the sanitary zones. Liaison surfaces between walls and floors as well as corners of surfaces shall be rounded. The pipes, ventilation holes and installation shall be so located as not to create non-clean nicks. Lighting, heating and air-conditioning equipment shall not adversely affect products during production and storage by design. The exhaust air-conditioning equipment shall be installed in such a way that the pollutants are captured preferably at the point of origin. The effluent line shall not adversely affect the ventilation conditions in the room.
(4) For special purposes, such as the production and processing of antibiotics, hormones, substances prepared by biotechnology methods, highly toxic or infectious substances, separate enclosed spaces designed for these purposes must be established.
(1) The premises for the production and control of sterile products must, in addition to the requirements set out in Section 8:
(a) be carried out in such a way as to prevent microbial and partial contamination;
(b) be pressurised in relation to ambient space by the intake of filtered air and permanently measured. The spaces are secured by a signalling device that announces audible air-conditioning failures,
(c) have a covered wiring of the electrical installation, as well as all other pipelines on the surface, have indirect heating in the rooms and waste in the aseptic production room without direct connection to the sewerage.
(2) Material preparation, own production, filling and sterilisation shall be carried out in separate premises and, where required, quality assurance shall be carried out in laminar flow.
(3) For aseptic manufacture and filling of products which are non-sterilisable in the final formulation, a special space of adequate purity shall be provided to prevent any secondary microbial contamination.
(4) The access of workers and the supply of materials to the premises for the manufacture and control of sterile products is possible through a release preventing the introduction of microbial and partial contamination.
(5) Investment projects, project tasks and projects relating to the production, preparation, control, distribution, storage of medicines, auxiliary substances, medical and packaging equipment are approved by the Ministry in the light of good manufacturing practice.
Equipment, machinery and apparatus
(1) Only equipment, machinery and equipment providing the required quality of medicines and other products shall be used in production. The location of equipment, machinery and apparatus shall be such as to avoid confusion, contamination and omission of production activities. Equipment, machinery and apparatus as a whole and in parts shall allow for thorough and easy cleaning and, where appropriate, the necessary sterilisation, especially before the manufacture of another product.
(2) Equipment, machinery and apparatus used in production and control must be regularly verified and validated. This activity must be documented. Specific rules apply to ensure consistency and accuracy of measuring instruments. 5)
(3) Records must be kept on cleaning and maintenance of equipment, machinery and equipment.
(4) In the case of permanently installed pipes (valves), they must be clearly marked for the purpose for which they are intended.
Sanitary measures
(1) Persons entering production premises are required to use protective clothing and equipment appropriate to the production process.
(2) There is a ban on eating food, drinking drinks, smoking and action contrary to the principles of personal hygiene.
(3) Organisations shall issue sanitary and hygienic procedures for the operation of workers before entering production and handling premises and during the production and handling of products.
(4) Sanitation and hygiene procedures provide for regular cleaning and disinfection of production premises and facilities. Compliance shall be checked regularly. The implementation and control of each sanitary activity shall be documented in writing.
Production documentation
(1) The production documentation consists of:
(a) technological reglement;
(b) technical standards, 6)
(c) the production order and packing order for each individual lot;
(d) standard working procedures;
(e) stability test, 7)
(f) records of batch production;
(g) records of ongoing production controls.
(2) The production documentation of each lot must:
(a) determine the name, quality and quantity of all raw materials, intermediate products and packaging to be used for production;
(b) identify clearly technological procedures;
(c) determine the standard and actual yields at all stages of production;
(d) identify detailed instructions and warnings for the production and storage of intermediate products, unfilled products and finished products;
(e) identify the quality and, where appropriate, the quality characteristics of the medicinal products and intermediate products with detailed guidance for their evaluation (control);
(f) comply with other standards supplementing or superior to it;
(g) use international or Czechoslovak names of medicines and excipients.
(3) The technological reglement and the downstream parts of the production documentation must correspond to the current state of production and control. are subject to a review after a maximum of five years.
(4) The record of batch production as determined by the manufacturing order and the packing order shall contain the following information:
(a) the name of the product, the batch number, the standard and the actual batch size,
(b) the name, date and time of manufacture of each production stage (each production phase);
(c) the quantity of each source and packaging material used in the manufacture and the number of release and tests;
(d) the production process and details of production, including an indication of the technological equipment used, of the yield achieved at each stage of production compared to the standard yield;
(e) a record of the interim production checks carried out and the results obtained;
(f) records of checks carried out on the cleanliness of premises and production facilities before and after the production and packaging of the lot, where appropriate;
(g) legible signatures of the worker who carried out the production process and of the worker responsible for the production activities;
(h) all analytical records relating to the lot;
(ch) the decision to release or release the lot with the date and signature of the official responsible for that decision;
(i) in the case of external production, documentation of the external manufacturer.
(5) The method of keeping the production documentation shall allow for a simple re-reconstruction of the production and inspection of each batch. The manufacturing documentation shall be archived for a period of one year from the expiry date or the shelf life of the product.
Production processes
(1) Medicinal products, excipients and medical and packaging equipment must be manufactured in accordance with Czechoslovak Pharmacopoeia, with approved technological reglement and technical standards. Production shall comply with the requirements under which the product has been registered or authorised for manufacture. The medicinal products for which the chief hygienist of the Czech Republic has given his consent must comply with the conditions set out therein. (8) All changes in the composition of the medicine, including the excipients, are subject to new approval by the Ministry. 9)
(2) The production organisation shall prevent confusion, omission of the prescribed manufacturing activity or disruption of the product by contamination and shall contribute to the reproduction of the constantly identical quality determined by continuous production checks.
(3) During production, the production equipment, machinery and apparatus, containers and packaging shall be marked with the information necessary to identify the batch produced and the stage of production.
(4) Production takes place in lots.
(5) Production activities, in particular for new production, must be validated.
(6) Before each production activity begins, the identity of the raw materials processed shall be verified, the purity of the premises and equipment and the presence of materials not required for the intended activity. Information on daily activities shall be entered in each production department.
(7) The organisation is required to maintain a system of information that allows an overview of all products that could be affected by repeated errors or failures in production processes.
Raw materials and packaging preparations
(1) Raw materials and packaging products shall be stored and labelled, sampled, identified, tested for the prescribed quality, released or rejected, labelled, stored and issued in such a way that there is no confusion, contamination or processing of unreleased materials during the said operations.
(2) Unsatisfactory raw materials and packaging products are clearly identified, must be separately stored and must not be used for production.
(3) Raw materials for the manufacture of paranteral medicinal products must not have evidence of release over two years of age, unless otherwise specified.
Marking and packaging
(1) Individual batches of medicines shall be marked and packaged only after appropriate examination and release for packing by the responsible official.
(2) Packing operations must be carried out in such a way as to avoid confusion between products or packaging material.
(3) The finished products are labelled on the packaging in accordance with the relevant regulations. 10)
External production
Where the execution of a stage of the production process is entrusted to an external contractor or takes place in premises for other organisations, the production conditions laid down in this decree must be fulfilled. The external manufacturer shall be included in the production record of the batch concerned.
Storage, distribution and complaints
(1) The medicinal products are stored and stored under conditions laid down in specific Regulations (8), (9) so that the individual batches are separated.
(2) The keeping of records of the distribution of each batch of the product shall, where necessary, allow the rapid and complete withdrawal of the batch of production from use.
(3) An organisation which is aware of injury, adverse reaction, adverse side effects and defects in the quality of medicines and medical devices is required to notify the Ministry and the State Institute for Drug Control (hereinafter referred to as the State Institute) without delay.
(4) In the event of a recognised complaint, the organisation shall take all necessary measures to prevent further production, distribution and use of defective products and the recurrence of the claimed defect.
ADMINISTRATIVE INDUSTRY PRACTICE IN THE REVIEW OF PREPARATIONS INCLUDED IN THE ESTABLISHMENT OF MEDICAL SERVICES
Workers
(1) The organisation is required to ensure that only personnel whose qualifications, working morale and medical condition guarantee compliance with the further requirements for their activities can work in the centralised preparation of medicines at pharmacies and other facilities of the National Health Institute (hereinafter referred to as the "Medical Service") 11.
(2) The organisation is required to establish a head of staff responsible for production and a head of staff responsible for quality management and to exclude any interference in their competence. These managers are:
(a) a leading pharmacist of a separate pharmacy (manufacture of pharmaceuticals, infusion solutions); or
(b) Head of the Unit for the preparation of sterile medicines, the Unit for the preparation of medicinal products and, where appropriate, the Unit for the preparation of medicinal products; or
(c) Head of the department of drug control and preparation of examiners and, where appropriate, a pharmacist at the drug control workplace.
(3) The qualifications of the pharmacy staff, their continuing training and professional management of their activities are governed by specific rules. 12)
Analysis and unification of the recipe
(1) The drug service shall carry out recipe analyses in order to obtain the basis for the possible transfer of preparation of individually prepared medicines to establishments where they will be prepared in concentrated lots.
(2) The tests are subject to medical regulations, applications for medical devices, other requirements and evidence of elaberration. The subjects of the analyses are in particular the average number of individually prepared medicines, the complexity of preparation and the frequency of the prepared medicines according to pharmaceutical and application forms. The analyses shall include the activities of all or, where appropriate, selected pharmacies in the district according to the purpose and scope of the concentrated preparation considered. The analysis results in a unification of the formula for optimal formulation drugs, using current knowledge in pharmacotherapy and technology.
(3) Unified recipes are included in a collection of receptors, in which regulations are selected with the highest frequency and with proven stability. Receptors are approved and issued by directors of national health institutions.
Workplace for focused drug preparation
(1) Authorisations for the centralised preparation of medicinal products are issued by the Director of the relevant National Health Institute. The director of the pharmacy services determines the workplace and scope of the focused preparation.
(2) In establishing the conditions for the centralised preparation and supply of larger territorial units, national health institutes may agree to concentrate the preparation of medicines to provide medical services on a territory beyond one district.
(3) The concentration of drug preparation must not be at the expense of the availability of the drug, on the contrary, it must monitor the shortening of the time from the administration of the prescription to the patient until the delivery of the medicine.
(4) For the workplace of pharmaceuticals intended for the centralised preparation of pharmaceuticals, they shall be issued after consultation with relevant regional experts in the fields of galenical pharmacy and pharmaceutical analysts of the operating order, including measures to comply with prescribed working procedures, control methods, operating regime and sanitation.
Space and equipment
(1) The premises for the centralised preparation of medicinal products must meet the purpose for which they are established. In determining the necessary space, it is based on the relevant provisions of the Typical Directive13) taking into account the expected volume and frequency of preparation. Other facilities, in particular storage facilities for medicinal and auxiliary substances, ready-to-use products and packaging, shall be eligible for self-preparation and control.
(2) The premises for the centralised preparation of medicinal products must allow for proper and efficient placement of devices and equipment, exclude the risk of confusion, prevent mutual pollution, exclude violations of prescribed technological practices and guarantee universal protection of medicinal products and workers. It shall allow for easy cleaning and disinfection and comply with the conditions of protection of air cleanliness.
(3) instrumentation equipment and other pharmacy equipment must meet the quality and safety requirements of the prepared medicinal products.
Documentation
(1) The prescription for a medicinal product is given by a Czechoslovak Pharmacopoeia or by another prescription, or in an approved receiver.
(2) For each medicinal product a technological prescription shall be drawn up which determines the method of preparation and the extent of its control. It contains the name of the product, application form, composition, equipment and preparation procedure. The technological regulation shall be issued by the Director of the Medical Service, on a proposal from the head of staff responsible for the preparation of medicinal products and after approval by the Regional Expert in Galenical Pharmacy.
(3) Part of the technological regulation is a mandatory control regulation containing control methods including stability conditions, determination of shelf life, determination of packaging and details of labelling. The Binding Control Code, including the Control Methods, shall be issued by the Director of the Medical Service, on a proposal from the Chief Executive responsible for Quality Control and after approval by the Regional Expert in Pharmaceutical Analytics.
(4) The centralised preparation of medicinal products shall be documented and shall allow for the traceability of all technological processes and activities. They shall include the preparation data, the total quantity of the preparation and the number of packages, the intermediate production control data, including the number of the release protocol, the date and signatures of the responsible staff.
Preparation of medicines
(1) The preparation of the medicinal products must be in accordance with the Czechoslovak Pharmacopoeia, the technical standard (10) and the approved technological procedure.
(2) All activities in the concentrated preparation of medicines shall be carried out under the constant supervision of professionals. Before preparing, it shall be ensured that the equipment and equipment used and the necessary measures are clean and functioning.
(3) Medicinal products in concentrated preparation are prepared in lots.
Labelling and packaging
(1) Each package of product must be labelled accordingly. The label shall contain, in accordance with the requirements of the Czechoslovak Pharmacopoeia, or other standards of Latin or Czech name, for other composition preparations, batch and shelf life, or exspiration.
(2) The indication of the lot shall include the code number of the day, month, year; if more than one batch is prepared on the same day, this indication shall also include an indicative indication. The batch number must correspond to the record number of the concentrated preparation (Section 23 (4)).
CHECKS ON VIAL, EXCIPIENTS, HEALTH AND OBAL TECHNICS
Subject matter of control
The subject of the check shall be:
(a) medicines;
(b) excipients,
(c) medical devices; and
(d) packaging equipment.
Bodies and equipment for inspection
The authorities and inspection facilities shall be:
(a) organisation (§ 2),
(b) State Institute.
Content and scope of control
(1) The quality check of pharmaceuticals, excipients, medical and packaging equipment shall verify:
(a) the composition, completeness of packaging, labelling, storage, storage and completeness of records of production, preparation and control;
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Regulation Information
| Citation | Decree of the Ministry of Health of the Czech Republic No. 284 / 1990 Coll., on good manufacturing practice, quality management of human medicines and medical and packaging equipment |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.07.1990 |
|---|---|
| Effective from | 01.09.1990 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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