Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
According to WHO – Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
According to the International Pharmaceutical Excipients Council (IPEC) of Europe The supply chain of a pharmaceutical excipient starts at the point of manufacture and continues until used by the finished product manufacturer. Apart from the manufacturer, other parties may be involved in the chain, including distributors, transporters and warehousing companies, forwarding agents, traders, and brokers. Although some of these parties do not have direct contact with the product (e.g., transporters), those that do (e.g., re-packagers, processers, samplers, testers) require a higher level of control and Good Distribution Practice (GDP) to be applied.
Standards Certification Council offers a comprehensive simulated Inspection. We identify the areas where the current compliance status needs to be improved. The Audit Report will summaries the GAP between the requirements laid down in the different legislations and Guidance documents and contains recommendations to close the GAP. Standards Certification Council offers Verification Statement under the terms.