GOOD MANUFACTURING PRACTICE OF DRUGS

Ten GMP points for all forms of drug products are:
1. PERSONNEL: Properly selected, trained and motivated staff which leads to “ZERO DEFECT CONCEPT”. All workers should be free from contagious diseases and they should wear neat and clean overalls while working. They should also wear clean caps and cotton gloves.
2. MEDICAL SERVICES: There should be adequate facilities for FIRST AID. Time to time check up of workers. Facilities for vaccination and inoculation against epidemic diseases should be provided.
3. SANITATION: A written sanitation program shall be available including: Area to be cleaned. Cleaning interval. Cleaning procedure to be followed. The manufacturing area should be cleaned and free from accumulated waste. Eating, smoking and unhygienic practices should not be permitted in manufacturing area
4. BUILDING: Suitable size, design and location are necessary for GMP. Building should have proper construction, adequate space, ventilation measures, etc, etc. For parenterals sterile area should be constructed.
5. EQUIPMENT: Manufacturing units should be inert, non-reactive non-additive and should be designed and maintained to: Be suitable for its intended use. Be easy to clean. Minimize the contamination of product under process. It should be capable of REPRODUCTIVITY.
6. STARTING MATERIAL: All the starting materials shall be: Identified and their containers examined for damage. Properly stored. Properly sampled by Quality Control Department. Tested for compliance with their stated specifications and should be marked accordingly. Approved starting materials shall be labeled properly. Rejected materials shall be identified as such and shall be destroyed or returned to supplier as soon as possible.
7. MANUFACTURING OPERATIONS: All manufacturing operations should be supervised by qualified and experienced personals. Before any operations, proper cleaning and testing should be done for all equipments. Contents of all vessels and containers used in the manufacturing should be identified and labeled. Sterile operations should be performed in especially designed area marked as “STERILE AREA”.
8. LABELING: Labeling and packaging material for different preparations should be stored and handled in such a way that they should not be intermixed. To prevent packaging and labeling errors a known number of labeling and packaging units should be issued and coded if required.
9. QUALITY CONTROL SYSTEM: The Quality Control Department should have the following principal duties: To prepare and issue detailed instructions in writing for carrying out each test and analysis. To release a reject each batch of starting material. To control and release labeling materials and final containers. To evaluate the quality and stability of finished product. To establish shelf life specifications and expiry date.
10. CONTROL OF RECORD: Personnel record i.e. which person is doing the specific operation along with helpers. Batch number and batch size record. Sanitation record. Maintenance of analytical record.