What to expect during GMP Inspection

[Adam Fleming]

Regulatory agencies such as the FDA conduct inspections for product-related Good Manufacturing Practice (GMP) in the course of assessing an application for marketing approval. The basic purpose of product-related GMP inspections is to check for compliance with the GMP guidelines set out in the International Conference on Harmonization (ICH) and national and local GMP regulations. GMP is the slightest standard that a manufacturer has to mandatorily meet in its production processes. The aim of implementing GMP is to ensure that products

o  Are of consistently high quality

o  Are appropriate to their intended use, and

o  Meet the requirements of the marketing application or product specification.

Many factors trigger a product-related GMP inspection

The reasons for which these product-related GMP inspections can be triggered are quite similar to those that trigger an OSHA inspection. It can be due to any of these:

o  A whistleblower

o  In the course of inspecting other products in the facility

o  By regulatory agencies other than the one that is meant to carry out the inspection

o  When the regulatory agency comes to know of or suspects a breach.

Thorough preparation is the key to success at a product-related GMP inspection

There are several aspects to a product-related GMP inspection that needs to be borne in mind. They could happen simultaneously, or they may happen after an announcement to this effect.

Given the complexity of the nature of a product-related GMP inspection; it is essential to understand the intricacies of this exercise. A failure at a product-related GMP inspection is sure the cost the organization a lot in terms of money and effort.

It is because of the critical importance of success at a product-related GMP inspection that an organization needs to be thorough in its preparation for such an inspection. Organizations that go through product-related GMP inspections need to be ready for a product-related GMP inspection from a number of important perspectives.

Training on how to prepare for a product-related GMP inspection

This is the training a webinar from Compliance4All, a very well-known provider of professional trainings in all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Peggy J. Berry, the President and CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. Understanding how to be prepared for a product-related GMP inspection from Peggy is easy. All that is needed is to visit http://www.compliance4all.com/control/w_product/~product_id=501225L... to enroll.

The aim of this webinar from Compliance4All is to offer practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible. The core components of ensuring these include:

o  Ongoing readiness for inspections

o  Rehearsals and preparation for successful facility inspections, and

o  Knowing how to respond to findings by regulatory agencies.

Peggy will offer in-depth insights into these aspects of product-related GMP inspection.

Handling inspections can be a tough job

Regulatory agency inspections are not the easiest of people to handle and manage during a product-related GMP inspection. They can be very fussy and tough. Organizations that have no idea about how to manage product-related GMP inspections can have a difficult time with these inspectors, no matter from various regulatory agencies they hail.

At this webinar, Peggy will show what to expect during the product-related GMP inspection. She will also show the ways of successfully and efficiently streamlining and managing the inspection. She will also highlight the importance of adequate follow-up during and after the inspection.

During the course of this 90-minute session, which will be of tremendous use to professionals related to GMP, such as Design Engineers, and those in manufacturing, supply chain, technical operations, Quality Control, Quality Assurance and Regulatory Affairs, Peggy will cover the following areas:

o  Types of Inspections (for cause, pre-approval, periodic ) > API & FDF

o  Notification Timing

o  Foreign Facilities

o  What to expect during Inspection

o  Do a company audit as the FDA would (fall dress rehearsal)

o  Make adjustments as needed/address issues/take needed actions

o  Managing the Inspection

o  Inspection on follow-up.