Completing a Good Manufacturing Practices (GMP) audit report prior to 2020 was simple. Companies had many ways to get theirs done, and a large percentage opted for performing their own onsite audits at their suppliers’ facilities, and then putting together the report themselves. This year however, with travel so limited, this option is difficult if not impossible.
GMP in a nutshell
Good Manufacturing Practice (GMP) ensures products are constantly produced and controlled to the quality standards appropriate for their intended use and conform to the regulatory requirements set by health authorities. GMPs are essential to any manufacturing industry and are often required to be implemented by national governments.
The tenets of GMP mainly relate to:
• standardization of product quality (consistency, efficacy, shelf-life, manufacturing practices)
• assurance of product safety (sterility, content consistency/active ingredients, lack of contaminants)
• good documentation practices (GDocP) as a crucial part of assessing quality controls, testing reports and more
A GMP audit is a very important regulatory process. Pharmaceutical manufacturers are required to carry out GMP audits of their suppliers or have audits conducted on their behalf by qualified, experienced auditors. Multiple checklists exist online to guide companies through the audit. There are also many external, independent companies out there that provide GMP auditing services for pharmaceutical manufactures to meet their audit requirements for regulatory authorities.
Whether you choose to use an independent auditing company, or perform the audit yourself, is entirely up to you. Some of the elements to take in to account are budget, time, and availability to travel. The latter is clearly a major consideration in 2020.
Our solution for you during COVID
Luckily, during these challenging times, we have the perfect solution for you! Several independent auditing companies have carried out full audits at the majority of Teva api manufacturing sites, and can provide you with personalized and comprehensive reports dedicated to the areas most relevant to your operations.
The reports focus on our facilities’ quality management systems, cover a large number of products, and are recognized by QPs and regulatory authorities globally. So you’ll essentially be able to fulfill your regulatory requirements without the need to travel.
For more information about this service and the various auditing companies, please contact us .
If you’d still prefer to perform an onsite audit or remote desktop audit, it may be possible, depending on individual circumstances. Please do not hesitate to contact us.