Materials Management of GMP Manual
- 发布时间：2021-05-28 09:24
Materials Management of GMP Manual
- 发布时间：2021-05-28 09:24
Questions and Answers —————————————————————————————————
1.What are the environmental requirements when sampling accessories and packaging materials?
A: Warehouse area can set sampling room, air cleanliness class of sample environment should match the production requirements. If not sampling in sampling room, there should be a measure to avoid pollution and cross-contamination(for example: sampling car with purification function can be applied)
2.What are the requirement in the process of materials storage?
A：Materials, intermediate products and finished products with special requirements for temperature, humidity or other conditions should be stored under specified conditions. Solid and liquid raw materials should be stored separately; Volatile materials avoid polluting other materials. Prepared, selected, and pretreated drugs materials shall be packed in clean containers or packages and strictly separated from undressed and unprocessed drugs materials. Materials should be stored according to the stipulated period of use. If there is no stipulated period of use, the storage generally can not exceed three years. Re-inspection will be made after the expiration date. There should be a periodic re-inspection system in material storage period, if there are special circumstances, re-inspect in time. Inflammable, explosive, toxic and corrosive dangerous goods should be stored in specified dangerous goods warehouse that meets fire protection requirements, and has fire safety facilities.
3.What are the requirements for the storage and use of drug labels and operation instructions?
A: Drugs labels and operation instruction should be kept and collected by special personnel, The requirements are as follows:
(1)Drugs labels and operation instruction should be kept in varieties or specifications, or be stored in special counter or warehouse. They are distributed according to packaging instructions and received according to actual needs;
(2)Labels should be provided in counting, the applicant checks that whether the signature, the number of uses, the number of damages and the remaining number are consistent with the number of requisitions. Remaining labels or damaged labels with batch numbers should be responsible for someone, and be destroyed in counting and supervised by QA.
(3)Label issuance, use, and destruction should be recorded, and a dedicated person should be responsible.
4.What must be indicated on the label and instruction manual? What are the regulations for printing, distribution and use?
A: The contents of drugs’ labels and instruction must comply with the related terms in Administrative Regulations for Drug Packaging, Labeling and Instruction, and must same as the content, style and text approved by the drug supervision and administration department.
Labels and instruction manuals must be printed, distributed, and used after being verified by the quality management department of the enterprise.
The specific requirements for labels, can reference the related regulations of the detailed rules (provisional) of drug packaging and labeling specifications in the Notice of Detailed Rules for Pharmaceutical Packaging and Labeling (Interim)" which NMPA(2001) printed and distributed.
5.How many status signs the warehouse materials management have?
A: Material management can be divided into: a.waiting for inspection, yellow sign; b.up to standard, green sign; c.below standard, red sign; d.sales return, blue sign.
6.How to deal with disqualification package materials?
A: Printed package materials all are the drug special packaging. The disqualified printed packages must be destroyed in situ, otherwise the serious consequence will be caused due to the material loss. But for the disqualified carton packages, if they are to be made into pulp, they must be shredded and moved into the pulp tank under the supervision of the quality supervision department.
7.Why saying supplier management is one of the important contents of GMP?
A: Original and auxiliary package material as the starting materials of drug production, its quality will directly affect the final quality of drugs. There are many incidents of unqualified drugs produced due to the errors or confusion of the original and auxiliary package materials in the supplier’s production process. Therefore, it is necessary to strengthen the management of suppliers, control the quality at the source, and then control and manage the acceptance and use process, so as to ultimately ensure the quality of the drugs produced.
8.What measures should warehouse take?
A: Five measures are rodents, birds and other animal prevention, insets prevention, mycete and moist prevention, fire prevention, burglary prevention.
9.What is drug inner packaging?
A: Drug inner packaging is the packaging which directly touch with drugs(such as ampoule, oral liquid bottle, aluminum foil for blister packaging、composite film for pill packaging of tablet or capsule)
10.What’s categories of drug packaging materials divide into?
A: Classification of drug packaging materials: drug packaging materials are divided into three categories: Ⅰ, Ⅱ, and Ⅲ.
Class I drug packaging materials refer to drug packaging materials and containers that are directly contact with drugs and are directly used.
ClassⅡdrug packaging materials refer to drug packaging materials and containers that are directly contact with drugs but easy to clean, can and need to sterilize after cleaning in actual using process.
ClassⅢdrug packaging materials refer to drug packaging materials and containers that may affect drug quality directly except classⅡand classⅢ.