GMP NEWS 2018

Auditing Starting Materials - new APIC Guideline defines Standards

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.

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Again FDA emphasises Importance of written Contracts

The US Food & Drug Administration (FDA) has issued a Warning Letter to a US company recommending to have a look at FDA's Guidance on Contract Manufacturing Arrangements.

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Warning Letter due to falsified Data and poor Maintenance

The attempt to conceal hygiene deficiencies with inaccurate lab data resulted in a virtually inevitable Warning Letter after an FDA inspection. Read here, which violations of fundamental GMP rules for maintenance and cleaning of production equipment at an API facility were criticised by the inspectors.

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Ph. Eur. Packaging Chapters adopted

Several revised Ph. Eur. packaging chapters have been recently adopted by the Ph. Eur. Commission. These general chapters will appear in Ph. Eur. 9.6. Read more about the revised chapters on plasticized PVC materials and glass containers.

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The new Annex 1 and 5 µm Particles

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.

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FDA opens Docket on Continuous Manufacturing

In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.

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Impact of the Annex 1 Revision on Pharmaceutical Water

The long-awaited draft of the new Annex 1 was published in December 2017. Besides mainly contents concerning sterile production, it also contains various updates on the manufacturing and distribution of water to be used in pharmaceutical production.

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New EU Template for GMP Non-Compliance Statement

The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.

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New USP Chapter <922> Water Activity

The United States Pharmacopeia, USP, posted the announcement of the elaboration of a new general chapter <922> on Water Activity.

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New EU Regulation lowers BPA Limit

The European Commission published its final Bisphenol A (BPA) Regulation. The Regulation lowers the BPA limit from currently 0.6 mg/kg to 0.05 mg/kg. This limit also applies for varnishes and coatings. Read more about the final Commission Regulation (EU) 2018/213.

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Warning Letter for systematic invalidating of OOS Results

If inspectors find deficiencies in quality control, they usually make sure to go into detail. Find out in which cases the invalidating of OOS results and exceeded bulk hold times are not tolerated in FDA inspections.

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Number of reported Counterfeits on the Rise

During the last year, the notifications on mechanical defects and reported suspicions of counterfeits increased. Distributors should also be interested in these figures.

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How to prepare for an inspection?

GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?

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What is the current Status of GDP Implementation?

The European GDP Association evaluated the current implementation status of the EU-GDP guidelines in a survey. The response was interesting.

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Can the (√n+1) Rule be accepted in Sampling Plans?

Is a sampling plan based on the (√n+1) rule acceptable for determining the correct number of samples? Health Canada took up this question in their "Good Manufacturing Practices (GMP) Questions and Answers". Read more under which conditions the use of sampling key (√n+1) is possible.

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FDA Requirements on Process Validation - a Warning Letter provides Information

The coming into force of the new FDA guidance on process validation in 2011 led to a shift in paradigm. Validation is a three-stage life cycle now and also includes commercial production in stage three. What does that mean for implementing the FDA proces validation guidance though? 

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How a 483 turned into a Warning Letter for Celltrion in South Korea

The South Korean company Celltrion had received a so-called 483 FDA report as a result of inspections performed in May and June 2017. Deficiencies were mainly observed in the aseptic area. Due to the - in their opinion - insufficient answer to the 483 report, the FDA has now issued a Warning Letter.

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EMA: HMPC Meeting Report published

On 27 November, 2017, the EMA's Committee on Herbal Medicinal Products (HMPC) published the HMPC meeting report about their 79. meeting held from 20-21 November, 2017. Learn more about the key issues discussed during the EMA HMPC meeting.

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Missing Audit Trail Review led to Warning Letter

Chinese manufacturer Zhejiang Ludao Technology received an FDA Warning Letter in February, 2018. During the FDA inspection, the missing Audit Trail Review for the HPLC system was particularly criticised.

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Warning letter to Topical Products Manufacturer

Microbiological testing of topical drug products to prove compliance with the specifications prior to release and correct labelling is mandatory for products applied to the skin. Find out, what GMP violations regarding the manufacturing, testing and labelling FDA inspectors found during an inspection.

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