GMP NEWS 2021

Dealing with Particulate Findings in 100% Visual Inspection

Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?

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Audit Trail-Deviations in the course of Inspections

Computerised systems are also audited as part of inspections by the authorities. Klaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen, has compiled a TOP 3 list of the most frequent complaints for 2020 based on his inspections. TOP 1 on the list is the audit trail review. What deficiencies were found here?

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FDA Warning Letter Highlights the Importance of Analytical Methods Validation and System Suitability Tests

In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.

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Medical Cannabis in Malta

Malta´s Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.

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FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients

The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.

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Nitrosamine Impurities: FDA Rejects the Extension of Deadline for Submission of Risk Assessments

The U.S. Food and Drug Administration has set a narrow window for the submission of risk assessments on nitrosamine impurities for drugs containing chemically synthesised APIs. Read more here about the arguments used by the pharmaceutical industry to request an extension of the deadline and the reasons given by the FDA for rejecting this request.

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Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents

Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.

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Deficient Cleaning and Transfer of a Non-Validated Manufacturing Process Lead to a Warning Letter

During an inspection of an Indian pharmaceutical manufacturer by the FDA, several serious deficiencies were discovered. For example, the cleaning of multipurpose equipment was criticised, and the transfer of a non-validated manufacturing process led to further complaints. Read more here.

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FDA Inspection Compliance Program for Combination Products

Combination products are products that are subject to different sets of regulations. Such products may, for example, consist of a drug and a medical device, or a biological component may be added. Because of the different product components, special monitoring procedures are required.

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Remote Audits from the Perspective of Notified Bodies

We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to Notified Bodies on remote audits have been published.

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EMA publishes updated Question and Answer Document on Combination Products

With the EU regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostics (IVDR) coming into force on May 21, 2021, new requirements have been/will be imposed on combination products with regard to their medical device component. There is an updated question and answer document (Q&A) from the European Medicines Agency on current issues.

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Proposed new USP Chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units

In the Pharmacopeial Forum, PF 47(4), a proposal of a new USP Chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units, addressing the common use of Uniformity of Dosage Units <905> as a batch release test, has been published for comments.

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Finally published: Reflection Paper on GMP and Marketing Authorisation Holders

In January 2020, EMA published a draft of a so-called reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder". Now the final document has been published.

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US Congress is concerned about FDA Inspection Backlog

In a letter sent directly to Janet Woodcock, FDA, the Congress of the United States expresses its concerns about a backlog of pharmaceutical manufacturing facility inspections and human drug applications.

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New WHO Draft on GMP for IMPs

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GMP for IMPs.

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EMA Drafts on Quality Requirements for IMPs

The EMA has published two draft guidelines on the quality requirements for IMPs (small and large molecules). According to the Agency, the documents are to be seen in connection with the Clinical Trials Regulation (EU) No. 536/2014 which is expected to become applicable in January 2022.

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New WHO Draft on GxP for Development

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GxP for Development.

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Risk Assessment for On-Site Inspections

PIC/S has developed an FMEA-based risk assessment for routine on-site inspections (Covid-19 Risk Assessment for National Routine On-Site Inspections).

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Revision of USP <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples

In the Pharmacopeial Forum, PF 47(4), a proposal of USP Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples has been published for comments.

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Protective Properties of Colored Glass Containers

USP´s General Chapters–Packaging and Distribution Expert Committee (GCPD EC) proposes to replace spectral transmission with spectral absorbance for amber glass containers based upon wall thickness.

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