cGMP Requirement for Pharmaceutical Manufacturing

Production must follow all Principles of cGMP in order to get Quality defined by Regulatory Authorities.

As per EudraLex Volume 4:

1. Production should be performed and supervised by trained & qualified staff.All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be done in accordance with written procedures.

2. All incoming materials should be checked to ensure that the consignment corresponds to the order.

3. Damage to containers and any other problem which might affect the quality of a material should be investigated, recorded and reported to the Quality Assurance Department.

4.Intermediate and bulk products purchased as such should be handled on receipt as though they were starting materials.

5.All materials and products should be stored under the appropriate conditions established by the manufacturer (COA).

6. Product yield and reconciliation of quantities, should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.

7. At every stage of processing, products and materials should be protected from microbial and other contamination.

8. At all times during processing, all materials, bulk containers, major items of equipment and rooms used should be labelled

9. Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occurs, it shapl be initiated , with the involvement of the Quality Assurance department.

10. Access to production premises should be restricted to authorised personnel.

Read also:

Resource Person: Hassan Hussein

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