External GMP Auditors

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

483s During cGMP Inspection of Sterile Manufacturing Site

  • Lack of time limits between product manufacture and filling
  • Lack of filter validation for microbial challenge and extractables

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Why Audit Your Supplier?

• 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

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Training the Untrained

The first step in GXP Auditor training is to select Auditor candidates.

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What to Audit in a Computer System?

  • User Requirement Specification (URS)
  • Validation
  • Change Control

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Interview Do’s During a FDA Inspection

Interview Dos and Don’ts


• Answer all questions honestly

• Say “I don’t know” or “I’ll get the answer for you;”

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Who is Responsible for Quality & GMP Compliance?

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

Advantage & Disadvantage of Mock Pre-Approval Inspection


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.

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How to Develop An Effective GMP Audit Schedule?

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

Follow-Up GMP Audit

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