Tasks of Quality Control Unit during Validations - FDA Perspective
In addition to guidelines, interpretations of the FDA's CGMP rules can often be found in Warning Letters. A current Warning Letter describes the FDA's expectations of the Quality Control Unit for validations, among other things.
Final GCP Guideline on Computerized Systems and Data Integrity
The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.
The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.
At the end of July 2022 ISPE published an updated version of the widely accepted GAMP®5 guidance on 'A Risk-Based Approach to Compliant GxP Computerised Systems'. Read a first short review about the content of the revised version here.
What Errors can occur with Swab Sampling during Cleaning Validation?
Two sampling techniques are generally used in cleaning validation. The rinse test and the swab test. The following are notes on potential issues with the swab test.
Statistical Sampling: an Underestimated Element of Process Validation?
In a recent FDA Warning Letter, the FDA criticizes inadequate process validation for a semi-solid dosage form. What exactly did the FDA find inadequate?
Cloud Computing: Common Certifications (e.g. ISO 27000 ff) and their Role in GxP
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 6: Are common certifications (e.g., 27000ff) reliable evidence that a cloud service provider is suitable, or what requirements must a certification fulfill in order for it to play a role in the suitability of a CSP?
Cloud Computing: Legal basis for cloud solution in a GxP environment
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 5: The AMWHV (Arzneimittel- und Wirkstoff-Herstellungs-Verordnung) requires that all data according to the manufacturer's authorization reside on the premises. Is then a cloud solution possible at all?
Cloud Computing: Are SaaS closed systems per 21 CFR Part 11?
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 4: Are SaaS closed systems per 21 CFR Part 11?
ICH Q9 Quality Risk Management published as Revision 1
In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.
Cloud Computing: Reasons for choosing the particular Cloud Model?
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?
Risk Analyses do not always help - Example of Cross-Contamination
With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.
USP-NF Stimuli Article on Quality by Design (QbD) Principles in Method Development
In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.
Cloud Computing: Cloud Models in the GxP environment
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 2: What cloud models are there and where do they have applications in the GxP environment?