GMP News - Analytical Quality Control

11.04.18

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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04.04.18

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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03.04.18

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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28.03.18

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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28.03.18

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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28.03.18

Drafts of USP Packaging Chapters to be redeveloped

The USP recently posted the announcement of its intent to cancel and redevelop the drafts of packaging chapters previously published in the Pharmacopeial Forum. Read more about USP´s chapters on glass containers and elastomeric closures.

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21.03.18

Revised Ph. Eur. monographs: Plastic Syringes and Blood Transfusion Sets

The revised versions of two Ph. Eur. general packaging chapters have been published for comment in Pharmeuropa. Read more about 3.2.8. Sterile single-use plastic syringes and 3.2.6. Sets for the transfusion of blood and blood components.

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14.03.18

FDA Warning Letter due to Faulty Sampling

Drug manufacturer Shanghai Weierya Daily Chemicals in China received an FDA Warning Letter in February 2018. During the inspection, the inadequate sampling when testing active pharmaceutical ingredients and excipients was criticised. Read more about the recent Shanghai Weierya FDA warning letter.

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07.03.18

Measurement Uncertainty for the Pharmaceutical Industry

The USP recently published a stimuli article regarding the discussion of measurement uncertainty (MU) which is a component of the lifecycle approach to analytical procedures. Read more about the USE OF MEASUREMENT UNCERTAINTY IN THE PHARMACEUTICAL INDUSTRY.

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06.03.18

Ph. Eur. Draft on PAT

Recently a draft monograph on PAT has been published for comment in Pharmeuropa. Read more about Ph. Eur. chapter 5.25. Process Analytical Technology.

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28.02.18

Warning Letter due to Non-Compliance with Specifications

Drug manufacturer Shanwei Honghui Daily Appliance in China has received an FDA Warning Letter in December 2017. During the review, the FDA criticised the company's failure to check certificates of analysis for compliance with the specifications. Find more information in the recent FDA Warnig Letter to Shanwei.

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21.02.18

FDA Warning Letter due to Non-Compliance with Specifications

The Indian drug manufacturer Kim Chemicals received an FDA Warning Letter in October 2017. During an FDA inspection, it was criticised that not all medicinal products and the active substances they contained had been tested for compliance with the specifications. Find out more about the Kim Chemicals FDA Warning Letter.

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21.02.18

Revised USP Chapter <671> Containers - Performance Testing adopted

With USP 41 - NF 36 the revised general chapter <671>  Containers - Performance Testing will become official on May 1, 2018.

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15.02.18

Revised USP Chapter for Elastomeric Closures now official

End of December the USP published its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.

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15.02.18

Specifications and Acceptance Criteria for Impurities: new FDA Principles!

The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.

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