GMP Auditing is a Science, and an Art. It is easy to read an FDA, PIC/S, MHRA GMP Guidelines, or a Procedure and check to see if they are being followed. Read more
- Lack of time limits between product manufacture and filling
- Lack of filter validation for microbial challenge and extractables
• It is a regulatory requirement
• GMP is a continuum of risk mitigation and a Supplier Audit is a way to mitigate the risk associated with that supplier
The first step in GXP Auditor training is to select Auditor candidates.
- User Requirement Specification (URS)
- Change Control
Interview Dos and Don’ts
• Answer all questions honestly
• Say “I don’t know” or “I’ll get the answer for you;”
Every employee has a responsibility to the company to ensure that his or her responsibilities are met, thus assuring a quality product is produced. Who is responsible for GMP Compliance? Read more
FDA style with a focus on the product seeking approval. Personnel can communication skills related to regulatory issues, specific documentation, retrieval, and presentation of critical documentation, and answer product-or quality systems-specific questions.
If we view one reason for Internal GMP Audits as a means of determining the effectiveness of our Quality & GMP system, then it follows that scheduling our Internal GMP Audits should reflect, and support our Auditing goals. Read more
A follow-up GMP Audit is generally associated with a specific and critical nonconformity. When a nonconformity is detected, it is given to the manager of the activity being audited for corrective action. Read more