Actions for Noncompliance of cGMPs in the Quality Control Laboratory

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

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Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors and even behavior towards the FDA inspectors during inspections are some of the reasons for which laboratories get hauled up by the FDA. The inappropriate or incomplete implementation of cGMPs in the Quality Control labs is a major area for which the FDA takes penal actions against them.

Most common areas of noncompliance

These are some of the most common areas in which the FDA is likely to find issues relating to cGMPs in Quality Control laboratories:

  • Out of Specification lab results
  • Laboratory error- improper analysis method, use of incorrect standards, and/or miscalculation of data
  • Operator error or non-process error
  • Fault in the manufacturing process
  • Product failures
  • Laboratory documentation and records
  • Validation of methods
  • Equipment errors
  • Problems with raw materials
  • Lack of in-process controls and specifications
  • Management of the laboratory
  • Unexplained anomalies

Ways of avoiding penal actions

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From about the 1980’s, the FDA has been targeting Quality Control laboratories ever more stringently. The way of avoiding receipt of 483’s, which could escalate into a Warning Letter if it not addressed properly, is to be aware of all the ways by which to meet the FDA’s requirements of cGMPs in Quality Control laboratories. Some of the steps a QC laboratory needs to take to avoid FDA actions include:

  • Carefully reviewing and analyzing the regulations, inspectional guidance, 483 observations and Warning Letter and internal audit observations and deviations
  • Thoroughly reviewing laboratory practice and procedures
  • Gaining knowledge of the areas the investigators review and the type of observations that are made in other organizations and using this information to ensure that their laboratory operations are improved

Implementing actions based on these is at the root of its strategy for avoiding future observations of non-compliance and the issuance of 483’s from the FDA.

A valuable learning session on implementing these

How do laboratories do all these? How do they implement the correct cGMPs in their Quality Control laboratories, so that they meet the FDA’s compliance requirements? A webinar on this highly relevant and meaningful topic from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show how.

John Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System and Founder of The Lanese Group, which consults with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations; will be the speaker.

Please register for this highly valuable session by visiting and learn all that it takes to implement cGMPs in the Quality Control lab and avoid harsh penalties from the FDA, which could set your business back.

A thorough approach to imparting lessons on cGMPs

This is the approach that John will adapt for inculcating the lessons on cGMPs in the Quality Control laboratory:

He will apply one aspect of a proactive approach and review how this approach can be implemented for meeting regulatory requirements. He will then analyze 483 and Warning Letter observations to determine if similar observations that could serve as a benchmark to initiate further preventive actions could be made in the participants’ facility.

John will explain the non-conformances most often cited by the FDA, along with the relevant regulation. He will then show specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. John will use these real life examples to show to participants the ways of analyzing what went wrong. He will explain the systems, procedures and records the laboratory should have in place that would prevent a similar observation. He will also familiarize the participants with several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and are being followed.

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Key personnel in laboratories, such as Quality Control Laboratory Managers, Quality Control Laboratory Supervisors, Quality Control Analysts, Quality Control Microbiologists, Quality Assurance Managers, and Quality Auditors will gain immense benefits by participating in this webinar. They will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement after completion of this webinar.

John will cover the following areas at this webinar:

  • System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • 483 and Warning letter observations
  • Analysis of observations
  • Areas for preventive action.
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Good Manufacturing Practices (GMP) and Its Role in Quality Control

Good Manufacturing Practices (GMP) and Its Role in Quality Control

There is no ambiguity about the role of Good Manufacturing Practice (GMP) in Quality Control. They are conjoined to each other at the core.

First, a basic understanding of GMP in pharmaceuticals

Good Manufacturing Practices (GMP) is a set of principles that is applicable in its own set of ways to certain fields. GMPs constitute a set of guidances that sketches and shapes the aspects of production and testing, which can have a major effect on the quality of a product.

In the area of pharmaceuticals; GMP is a part of a Quality System that covers various activities that are part of pharmaceuticals. These include medical devices, pharmaceutical products, foods, diagnostics, and the manufacturing and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients (APIs).

A word about Quality Assurance

Quality assurance is part of a Quality System, which is the sum of all individual and collective factors that go into assuring the quality of a product. It is made up of all the requirements and arrangements that combine to make the medicinal product meet its quality criteria needed for its intended use.

Now, the conjunction of GMP in a Quality System

GMP is an integral part of Quality Systems. The inseparability of one from the other can be understood from the fact that their objectives are in complete unison. A Quality System for the manufacture of pharmaceutical products needs to ensure the presence of GMP, along with associated aspects such as good laboratory practice (GLP) and good clinical practice (GCP).

In addition, the following points relate the centrality of the role of GMP in Quality Control:

  • Operations relating to production, which are quintessential for Quality Control, have to be specified clearly in a written format. GMP requirements are adopted based on these
  • GMP consists of making sure that pharmaceutical products have the right materials and in the perfectly stated dose. This is stated as part of Quality Control
  • GMP and Quality Control are linked inextricably in relation to controls, as well. Aspects of in-process controls such as validations and calibrations are carried out in accordance with the terms set out in the two disciplines
  • While the product is manufactured in accordance with set principles of GMP; subsequent stages such as processing and checking of the finished pharmaceutical product have to ensure Quality Control
  • Some activities like storage and distribution, as well as evaluations incorporate the principles of both GMP and Quality Control to ensure safety and effectiveness of pharmaceutical products.

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