Decree of the Ministry of Health and the Ministry of Agriculture No. 355 / 1997 Coll.
Ordinance of the Ministry of Health and the Ministry of Agriculture establishing good manufacturing practice, good distribution practice and closer conditions for authorising the production and distribution of medicines
Valid
Order
Effective from 01.01.1998
355
DECLARATION
Ministry of Health and Ministry of Agriculture
of 18 December 1997
establishing good manufacturing practice, good distribution practice and closer conditions for authorising the production and distribution of medicines
The Ministry of Health and the Ministry of Agriculture, pursuant to § 75 (2) (a) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, hereinafter referred to as "the Act":
Preliminary provisions
According to this decree, the production and distribution of pharmaceuticals (1) and control of these activities are progressed; The decree also provides for the particulars of the application for authorisation to manufacture and distribute medicines.
For the purposes of this decree:
(a) contamination by biological, microbiological, chemical or physical contamination of material intended for the manufacture of medicinal products and medicinal products at each stage of production (hereinafter referred to as "material");
(b) a prescription for a medicinal product, a document containing the name of the medicinal product, its description, the quantity of each material intended for the manufacture of the medicinal product, the batch size and the prescribed yield of the medicinal product,
(c) an instruction document describing the process of own manufacture of the medicinal product (technology), the equipment intended for such production, the procedures for carrying out the ongoing production controls and the values to be achieved in such checks;
(d) by standard operating procedure, a document setting out the repetitive activities in the manufacture and distribution of medicinal products, with the exception of the procedures provided for in the instructions;
(e) the specification of a document containing detailed requirements to be complied with by materials and packaging of medicinal products;
(f) validating the verification that the actual manufacture of pharmaceuticals and material control procedures have reached, by default, the requirements laid down in the manufacturing regulations, instructions, specifications and documentation submitted in the framework of the marketing authorisation procedure (2) for a particular medicinal product.
ADMINISTRATIVE PRODUCTION PRACTICE
Principles
In order to ensure the standard manufacture of the medicinal product,
(a) a summary of the requirements referred to in paragraphs 4 to 10 is established and systematically and applied throughout it;
(b) checks are carried out on compliance with the requirements referred to in (a);
(c) the establishment and compliance with good manufacturing practice in the design and development of medicines; and
(d) records are made of the activities resulting from the requirements referred to in (a).
Staff requirements
(1) The type and extent of the medicines manufactured must correspond to the number of eligible staff (3).
(2) The additional requirements for manufacturers concerning workers (4) in the manufacture of pharmaceuticals are:
(a) the establishment of the staff members' duties; and
(b) mutual independence in employment relations
1. the staff responsible for their own manufacture of pharmaceuticals,
2. persons responsible for their own production and persons responsible for the quality control of medicinal products in medical establishments,
(c) laying down hygiene conditions to prevent contamination of materials and packaging of medicinal products; and
(d) carrying out initial and ongoing training and training of staff, focusing on the type and extent of activity in the manufacture of medicines.
Spaces and equipment
(1) The premises and facilities intended for the manufacture of medicinal products must correspond to the type and extent of the medicinal products produced. These premises and facilities shall be maintained and controlled to ensure the required quality, safety and efficacy of the medicinal products.
(2) The organisation of production facilities and their interconnections must:
(a) to allow the various production activities to be progressively linked; and
(b) ensure easy cleaning and maintenance;
in order to avoid contamination and confusion of medicinal products, or any other undesirable effects on their quality, safety and efficacy.
(3) Spaces and equipment which may affect their quality, efficiency and safety in the manufacture of medicinal products must be checked for compliance with the requirements laid down in standard operating procedures.
Documentation
(1) The production rules, instructions, specifications and standard operating procedures must be updated.
(2) The record of the manufacture of the batch of the medicinal product shall permit monitoring of the course of its manufacture and shall be kept for at least one year after the expiry date of the batch of the medicinal product, but at least five years after the entry has been made.
(3) The content of the record shall remain permanently legible; the alert must be protected from damage or deterioration or loss, as appropriate. The system of electronically and photographically recorded records shall be validated.
Own production
(1) Technical and organisational measures must be taken before and during the manufacture of the batch of the medicinal product to prevent contamination and confusion of the medicinal product.
(2) Only materials and packaging which conform to the specified specifications shall be used for the manufacture of medicinal products.
(3) Individual manufacturing activities, ongoing production checks and validation must be carried out in accordance with pre-established production rules, instructions, specifications, standard operating procedures, documentation submitted in the framework of registration management2) and authorisation for the manufacture of pharmaceuticals. 5)
(4) Newly introduced manufacture of medicines must be validated; Similarly, the manufacture of medicinal products must be validated if changes have occurred during the manufacture which may affect the quality, safety and efficacy of the manufactured medicinal products.
Quality control
(1) Quality checks on materials and packaging of medicinal products are carried out in the laboratory; Such checks shall verify compliance with the specified specifications. The premises of the laboratory, equipment, apparatus and number of qualified staff in that laboratory shall correspond to the type and extent of checks carried out.
(2) The release of the batch of the medicinal product into distribution must be accompanied by the written consent of the qualified person. 6)
(3) Each batch of medicinal product must be sampled; such samples shall be kept for at least one year after the expiry date of the lot of the medicinal product from which they were taken.
(4) From materials intended for the manufacture of medicinal products, except solvents, gases or water, samples shall be kept for at least two years from the time of release of the manufactured batch of medicinal products; This time may be shortened if the stability of the starting substance is shorter.
Contract production and control of pharmaceuticals
The contract (7) on the manufacture of medicinal products or on laboratory control of medicinal products shall specify the obligations of the Contracting Parties to comply with good manufacturing practice and the manner in which the medicinal product is released for distribution.
Complaints and withdrawals of medicinal products
(1) The establishment and application of a system for the registration and assessment of complaints and complaints concerning the quality, safety and efficacy of medicinal products, including measures to withdraw a batch of medicinal products from circulation without delay if necessary, is part of good manufacturing practice.
(2) Complaints and complaints shall be dealt with in accordance with specific rules. 8)
ADMINISTRATIVE DISTRIBUTION PRACTICE
Principles
In order to ensure the standard distribution of medicinal products,
(a) a summary of the requirements set out in paragraphs 12 to 16 is established and systematically applied throughout it;
(b) checks are carried out on compliance with the requirements referred to in (a);
(c) an effective system for monitoring the movement of the batch of the medicinal product from the supplier to the customer is established and maintained; the system must allow, where necessary, the batch of medicinal products to be immediately suspended or withdrawn,
(d) medicinal products purchased from the supplier who is entitled to this activity, 5) and only medicinal products that have been registered, 9) have no longer been used and are packed in intact original packaging;
(e) medicinal products are sold only to authorised 10) medicinal customers; the medicinal products sold must meet the requirements referred to in point (d); and
(f) records shall be made of the activities resulting from the requirements referred to in points (a) to (e).
Staff requirements
(1) The type and extent of the medicines distributed must correspond to the number of eligible staff (3).
(2) Other requirements for distributors concerning workers (4) in the distribution of pharmaceuticals are:
(a) the setting of their duties;
(b) carrying out initial and ongoing training, including training of such staff, with a focus on the type and extent of activity carried out; and
(c) laying down hygiene conditions to prevent contamination of medicinal products.
Spaces and equipment
(1) The premises and facilities intended for the distribution of medicinal products must correspond to the type and extent of the medicinal products distributed. These premises and facilities shall be maintained and controlled to ensure the required quality, safety and efficacy of the medicinal products.
(2) The organisation of premises for the distribution of medicinal products must allow for the continuity of procedures, cleaning and maintenance in order to avoid contamination, confusion of medicinal products and, where appropriate, other adverse effects on the quality, safety and efficacy of medicinal products.
Documentation
(1) Standard operating procedures must be updated.
(2) Records made pursuant to Article 11 (e) shall be kept for at least one year after the expiry date of the lot of the medicinal product, but at least five years after the date of receipt of the alert.
(3) Records of the purchase and sale of medicines must include:
(a) the name of the medicinal product,
(b) date of purchase or sale;
(c) the name, surname, residence and identification number of the natural person who is the supplier or customer; for a customer or supplier who is a legal person, his trade name, registered office and identification number; and
(d) the quantity and batch number of the medicinal product purchased or sold.
(4) The content of the record shall remain permanently legible; the alert must be protected from damage or deterioration or loss, as appropriate. The system of electronically and photographically recorded records shall be validated.
Distribution
(1) The distribution of medicinal products must be carried out in accordance with standard operating procedures developed by the distributor.
(2) Medicines must be transported and stored in such a way that:
(a) the conditions laid down in the dossier submitted in the framework of the registration procedure are complied with, 2)
(b) the risk of their confusion and contamination has been reduced to the minimum possible; and
(c) they have not been damaged or, where appropriate, degraded.
(3) The returned medicinal product may be redistributed if:
(a) it is in the original undamaged packaging,
(b) has not been exposed to adverse effects on its quality, safety and efficacy;
(c) the customer agrees with the remaining period of application; and
(d) has been assessed by a qualified person (11) and found satisfactory in terms of quality, safety and efficacy.
(4) Medicinal products not complying with the marketing authorisation (12) must be stored separately from other medicinal products and must be clearly marked as non-marketable. The presence of such products must be immediately informed by the holders of the marketing authorisation decision (13) and the State Institute for Drug Control or the State Control of Veterinary Bioprafts and Medicines, as appropriate.
Complaints and withdrawals of medicinal products
(1) The establishment and application of a system for the registration of complaints and complaints concerning the quality, safety and efficacy of medicinal products, including measures to withdraw, where appropriate, the batch of medicinal products immediately distributed.
(2) The handling of complaints and complaints referred to in paragraph 1 shall be subject to a special rule. 8)
BLISTER CONDITIONS OF PRODUCTION AND DISTRIBUTION
Control activity
(1) The State Institute for Drug Control and the Institute for State Control of Veterinary Bioprafts and Medicines shall, according to their competence, check compliance with the requirements of good manufacturing practice and good distribution practice before granting authorisation for the manufacture and distribution of pharmaceuticals (5).
(2) The Constitution referred to in paragraph 1 controls compliance with the requirements of good manufacturing practice for drug manufacturers and compliance with the requirements of good distribution practice for drug distributors
(a) where there have been changes in the conditions under which the manufacture and distribution of medicines has been authorised; and
(b) following the removal of the deficiencies identified during the previous inspection.
(3) Checks are carried out on:
(a) manufacturers of medicinal products at least once every three years; and
(b) manufacturers of active substances and distributors of medicinal products at least once every four years.
(4) On the basis of the checks carried out under the preceding paragraphs, the relevant certificate may be issued at the request of the manufacturer. 14)
Forms of application for authorisation to manufacture and distribute medicines
(1) The application for authorisation to manufacture medicinal products shall contain:
(a) the name, surname, address and identification number of the natural person requesting such authorisation; where the legal person, its trading name, registered office and identification number so requests,
(b) the name, surname, residence of the statutory representative of the person referred to in (a);
(c) the type and extent of production required;
(d) the address of the place of manufacture;
(e) the name, surname, education and practice of qualified persons;
(f) the name, surname, residence and identification number of the natural person who, under contract, takes over part of the production or laboratory control; (7) the legal person's business name, registered office and identification number; and
(g) telephone and fax connections.
(2) The Annexes to the application for authorisation for the manufacture of medicinal products constitute:
(a) an extract from the Commercial Register, if it is a person registered in the Commercial Register, or a trade licence, or, where appropriate, an establishment document or statute issued by the competent authority of the State with other persons;
(b) list
1. active substances,
2. medicinal products, including their pharmaceutical forms,
3. medicinal products intended for clinical trial,
which will be produced and where they are produced,
(c) proof of the right to use premises, buildings, rooms and facilities for the manufacture of medicines; and
(d) details of compliance with the requirements of good manufacturing practice set out in Section 1 of this Decree.
(3) The application for approval of amendments to the conditions under which authorisation for the manufacture of medicinal products has been granted shall contain the particulars referred to in points (a), (c), (d) and (e) of paragraph 1 and in paragraph 2.
(1) The application for authorisation for the distribution of medicinal products must contain:
(a) the name, surname, address and identification number of the natural person requesting such authorisation; where the legal person, its trading name, registered office and identification number so requests,
(b) the name, surname, residence of the statutory representative of the person referred to in (a);
(c) the type and extent of distribution required;
(d) the address (s) of the storage premises,
(e) the name, surname, education and practice of the qualified person; and
(f) telephone and fax connections.
(2) The Annexes to the application for authorisation of distribution constitute:
(a) an extract from the Commercial Register, if it is a person registered in the Commercial Register, or a trade licence, or, where appropriate, an establishment document or statute issued by the competent authority of the State with other persons;
(b) proof of the right to use premises, buildings, rooms and devices for the distribution of medicines; and
(c) details of compliance with the requirements of good distribution practice set out in Section 2 of this Decree.
(3) The application for approval of amendments to the conditions under which authorisation for the distribution of medicinal products has been granted shall contain the particulars referred to in points (a), (c), (d) and (e) of paragraph 1 and in paragraph 2.
Final provision
This Decree shall take effect on 1 January 1998.
Minister for Health:
PhDr.
Minister for Agriculture:
Ing. Lux v. r.
1) Paragraph 2 (1) of the Act.
2) Article 23 et seq.
3) Article 15 (1) of the Law.
4) Paragraph 19 (1) (b) of the Law.
5) Paragraph 42 (2) of the Act.
6) Paragraph 19 (1) (a) of the Act.
7) Paragraph 19 (3) of the Act.
8) § 427 et seq. of Act No. 513 / 1991 Coll., Commercial Code, as amended. Act No. 634 / 1992 Coll., on Consumer Protection, as amended.
9) Paragraph 25 (7) of the Law.
10) Paragraph 20 (1) (d) of the Law.
11) Paragraph 20 (1) (a) of the Law.
12) Paragraph 26 (1) to (3) of the Act.
13) Paragraph 26 (4) of the Law.
14) Paragraph 9 (1) (a) (4) of the Law.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree of the Ministry of Health and the Ministry of Agriculture No. 355 / 1997 Coll., establishing good manufacturing practice, good distribution practice and closer conditions for authorising the production and distribution of medicines |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.1997 |
|---|---|
| Effective from | 01.01.1998 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0