GMP workshop

1GMP workshopRequirements for Factory Buildings and Facilities

1Requirements for the factory building

The site selection, design, layout, construction, renovation, and maintenance of the factory must comply with the requirements of drug production, and should be able to minimize pollution, cross contamination, confusion, and errors to facilitate cleaning, operation, and maintenance;

2Requirements for the production area

To reduce the risk of pollution and cross contamination, factories, production facilities, and equipment should be designed, laid out, and used reasonably according to the characteristics, process flow, and corresponding cleanliness level requirements of the drugs used. Factors such as the characteristics, process, and intended use of the drugs should be comprehensively considered to determine the feasibility of multi product sharing in factories, production facilities, and equipment, and corresponding evaluation reports should be provided.

3Requirements for storage area

The storage area should have sufficient space to ensure orderly storage of various materials and products such as raw materials, packaging materials, intermediate products, products to be packaged, and finished products that are awaiting inspection, qualified, unqualified, returned or recalled;

4Requirements for Quality Control Zone

Quality control laboratories should usually be separated from production areas; Laboratories for biological testing, microbiology, and radioactive isotopes should also be separated from each other; There should be sufficient area for sample disposal, retention, stability testing, storage of samples, and record keeping.

IIGMP workshopRequirements for Production Management

1The production and packaging of all drugs should be carried out in accordance with approved process procedures and operating procedures, and relevant records should be kept to ensure that the drugs meet the prescribed quality standards and comply with the requirements of drug production licenses and approvals;

2Establish operating procedures for dividing product production batches, which should ensure the uniformity of quality and characteristics of the same batch of products. Each batch of drugs should be assigned a batch number.

3Production operations of different varieties and specifications of drugs shall not be carried out simultaneously in the same production operation, unless there is no possibility of confusion or cross contamination.

4At every stage of production, products and materials should be protected from microbial and other contamination.During the production process, measures should be taken as much as possible to prevent pollution and cross contamination.

5All materials, intermediate products, or containers and main equipment used during production, as well as necessary operating rooms, should be labeled or otherwise marked with the names, specifications, and batch numbers of the products or materials being produced; If necessary, the production process and status should also be indicated;

6After each production is completed, the site should be cleared to ensure that there are no materials, products, or documents related to this production left in the equipment and workplace; Before the next production starts, the previous cleaning situation should be confirmed.

7Any deviation from the process specifications or operating procedures should be avoided as much as possible. Once a deviation occurs, it should be handled in accordance with the deviation handling operating procedures.

IIIEquipment requirements

1Necessary air lock rooms and exhaust equipment should be set up, and pressure difference control should be implemented in areas with different levels of air cleanliness.

2The risk of pollution caused by untreated or inadequately treated air re entering the production area should be reduced.

3Use validated or known effective cleaning and decontamination procedures for equipment cleaning; When necessary, residual substances on the surface of equipment in direct contact with materials should be tested.

4The air inlet of the drying equipment should have an air filter, and the exhaust should have a device to prevent air backflow.

5Fragile, flaky, and moldy utensils should be avoided during production and cleaning processes; Measures should be taken to prevent contamination caused by mesh breakage when using a sieve.