Entries by Regula Inspection Services

Advantage & Disadvantage of Mock Pre-Approval Inspection

Advantage 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.

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.

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.

Who Will Audit?

There are typically four factors used to determine who will audit.

Auditee Behavior

Sometimes the politics of auditee behavior can be quite amusing. Auditees telling you everything they think you want to hear can be humorous at times. Likewise auditees that absolutely refuse to cooperate can also seem strange.

On Time GMP Audits

It is time once again for the GMP Audit. An API Audit? An Excipient Audit? A Primary Packaging Material Audit? Who knows? Everything is ready. The auditees have been duly notified, and anxiously await your arrival. You have taken the time to prepare, studying the requirements and procedures.

How to Conduct a GMP Audit?

The GMP audit starts with the opening meeting. During the opening meeting, the audit team is introduced, the audit planned is reviewed, and audit criteria is confirmed. At this time any logistical needs are also addressed such as auditor meeting room, computer access, directions to the site, and so forth.