The Principles of Production Operations in a GMP Environment
Production operations must follow the principles of Good Manufacturing Practice to obtain products of the required quality and be in accordance with the relevant manufacturing and regulatory authorities.
Production should be performed and supervised by qualified people.
All material handling operations including:
- Receipt
- Sampling
- Quarantine Storage
- Labelling
- Dispensing
- Processing
- Packaging
- And Distribution
should be done in accordance with written procedures or instructions and documented when required.
All materials and products must be stored under the appropriate environmental conditions.
At all times during processing, all materials, bulk containers, major items of equipment and rooms used should be labelled or otherwise identified with an indication of the product or material being processed and the batch number.
Labels applied to containers, equipment or premises should be clear, unambiguous and in the company’s agreed format.
Detailed, standard operating procedures or SOPs are essential for each process that could affect the quality of the finished product.
There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
