Good Manufacturing Practice
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.
ISO 22716 GMP FOR COSMETICS
ISO 22716:2007 – Cosmetics GMP
Cosmetics – Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
The European Union’s new Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured according to Good Manufacturing Practices (GMP).
A manufacture of cosmetics can demonstrate compliance with GMP by implementing the International Standard ISO 22716:2007.
ISO 22716 presents a management systems approach to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines will provide your organization with practical methods for managing the many factors that can affect product quality. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution of finished products.
Standards Certification Council offers a complete conformity assessment solution including training, auditing and certification services. It is also possible to integrate your existing management systems of other standard such as ISO 9001 and ISO 14001, and saving you valuable time and resources.
IPEC PQC GMP
IPEC – PQG GMP FOR PHARMACEUTICAL EXCIPIENTS
According to the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), the quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential. In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.
IPEC – PQG Good Manufacturing Practice Guidelines FOR PHARMACEUTICAL EXCIPIENTS proposes GMP appropriate for the manufacture of excipients. The text of the guidelines aligns with the corresponding clauses in ISO 9001:2008. This Guide proposes to make an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry. Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.
Standards Certification Council offers a complete conformity assessment solution for IPEC – PQG GMP for Pharmaceutical Excipients including training, auditing and certification services. It is also possible to integrate your existing management systems of other standard such as ISO 9001 and ISO 14001, and saving you valuable time and resources.
ISO 15378 GMP FOR PACKAGING MATERIAL
ISO 15378:2011 – Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.