GMP (Good Manufacturing Practices) audits are used in the medical device and pharmaceutical industry in order to examine the way activities are performed, and to ensure compliance with regulatory standards. In essence, audits aim to verify that the products are manufactured in a way that will ensure that they are safe and achieve their goals.
Audits can be external (like regulatory inspections or client audits) or internal. Internal audits are audits carried out by the company to assess its own operations, detect instances of non-compliance, and implement corrective actions. Sometimes companies like to conduct mock audits, as a preparation to regulatory audits.
If you have subcontractors (e.g. vendors of APIs, packaging materials, etc.), you are required to ensure that your suppliers meet GMP standards. Gaps and deficiencies in your suppliers’ process impact your products, can lead to recalls, adverse events, and impact your reputation.
According to the regulations, you are responsible! In order to ensure that your suppliers comply with GMP standards, you may want to audit the way your key suppliers manufacture and deliver products to you, by conducting supplier audits.
Whatever your needs are, we can help!
Why YS Consulting?
We have a team of certified and experienced auditors who can perform a large array of audits:
- Preparations for regulatory inspections (FDA, Health Canada, MDSAP, Notified bodies, etc.)
- Internal Audits
- Mock audits
- Supplier Audits (for new or for established vendors)- We can also help you prepare towards inspections by regulatory bodies.
- Our team of experts are well familiar with andcan audit against various standards.
- We can help you implement a GMP audit program within your organization that will allow you to show your clients and the regulators that you are committed to quality and safety, and that your products are safe to use, and exceed expectations.
