Advertisements

Production department must follow all Principles of Good Manufacturing process in order to get Quality defined by respective Manufacturing & Marketing Authorities.

As per EudraLex Volume – 4 ( Chapter 5)

  • Production should be performed and supervised by competent people.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 or instructions and, where necessary, recorded.

  • All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled with the prescribed data.

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

  • Incoming materials and finished products should be physically or administratively quarantined immediately after receipt or processing, until they have been released for use or distribution.

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

  • All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation.

  • Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.Operations on different products should not be carried out simultaneously or consecutively in the same room unless there is no risk of mix-up or crosscontamination.

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

  • When working with dry materials and products, special precautions should be taken to prevent the generation and dissemination of dust. This applies particularly to the handling of highly active or sensitising materials.

  • At all times during processing, all materials, bulk containers, major items of equipment and where appropriate rooms used should be labelled or otherwise identified with an indication of the product or material being processed, its strength (where applicable) and batch number. Where applicable, this indication should also mention the stage of production.

  • Labels applied to containers, equipment or premises should be clear, unambiguous and in the company’s agreed format. It is often helpful in addition to the wording on the labels to use colours to indicate status (for example, quarantined, accepted, rejected, clean).

  • Checks should be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner.

  • Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occurs, it should be approved in writing by a competent person, with the involvement of the Quality Control department when appropriate.

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

 

Sr. No. Topics of Production
1. Prevention of cross-contamination in production

– Technical Measures

– Organisational Measures

2. Validation
3. Starting materials

– Active substances

– Excipients

4. Processing operations: intermediate and bulk products
5. Packaging materials
6. Packaging operations
7. Finished products
8. Rejected, recovered and returned materials
9. Product shortage due to manufacturing constraints
10 Equipment