Фармакопея.рф

Attachment No. 4 PARTICULARITIES OF MANUFACTURE OF MEDICINES FOR VETERINARY APPLICATION (EXCEPT IMMUNOBIOLOGICAL MEDICINES FOR VETERINARY APPLICATION)

Attachment No. 4

to the Rules of Good Manufacturing Practice

PARTICULARITIES OF MANUFACTURE OF MEDICINES FOR VETERINARY APPLICATION

(EXCEPT IMMUNOBIOLOGICAL MEDICINES FOR VETERINARY APPLICATION)

1. This Attachment shall apply to all medicines for veterinary application, except immunobiological medicines for veterinary application, whose manufacture is governed by Attachment No. 5 to these Rules.

I. MANUFACTURE OF ANTI-ECTOPARASITE MEDICINES

2. (5) Despite the restrictions set in Item 52 hereof, anti-ectoparasite medicines for external application are classified as veterinary medicines and included in the manufacturing license, and may be manufactured and packed in areas intended for the production of pesticides according to the principle of production cycles with time sharing. However other veterinary medicines may not be manufactured in these premises.

3. (6) To prevent cross contamination the manufacturer shall use appropriate and validated cleaning methods. It is required to take measures to ensure safe storage of veterinary medicines pursuant to the requirements of these Rules.

II. MANUFACTURE OF MEDICINES FOR VETERINARY APPLICATION WITH PENICILLINS

4. (7) The use of penicillins in veterinary medicine is not as risky with regard to hypersensitization of animals as when they are used by a human being. Documented cases of hypersensitization among horses and dogs were provoked by other toxic substances (e.g. ionophore antibiotics for horses). It is recommended to produce such medicines in special and isolated rooms, except cases when rooms are intended only for manufacturing veterinary medicines. In any case the manufacturer shall take all necessary measures to prevent cross contamination and to ensure the staff safety pursuant to the requirements of these Rules. In case of common rooms the manufacture of products containing penicillins shall be organized according to the principle of production cycles with time sharing and shall include appropriate and validated decontamination and cleaning procedures.

III. STORAGE OF SAMPLES

5. (8) Due to the great amounts of final packages of some veterinary medicines (in particular, additives), it is permitted to store samples of each batch of products without their final packaging. However the manufacturer shall ensure that the stored amount of retention samples of each batch of products is sufficient according to the requirements of these Rules.

6. (9) In any case the packaging for stored retention samples must be manufactured from the same material as the primary packaging for selling the product in the market.

IV. STERILE MEDICINES FOR VETERINARY APPLICATION

7. (10) In cases stipulated in regulatory legal acts of the Russian Federation, veterinary medicines subject to terminal sterilization may be manufactured in clean areas of a lower class against the requirements of Attachment No. 1 to these Rules, but no less than class D.

 

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