GMP NEWS 2016

USP Draft Chapter <771> Ophthalmic Products - Quality Tests

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a revised draft of general chapter <771> Ophthalmic Products-Quality Tests has been published for comment. Read more about the draft USP chapter <771> describing quality tests for opthalmic dosage forms.

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EMA - requirements for quality documentation concerning biological investigational medicinal products

The European Medicines Agency published a new draft on the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.

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FDA Scientists - West Nile Virus and Blood Donor Screening

FDA scientists gained insights in the genetic changes in West Nile Virus that could affect its spread and the ability of blood donor screening tests, future treatments, and vaccines to work effectively.

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EMA - Activities to reduce the Use of Animal Testing

End of July, the Europeam Medicines Agency published a draft "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs". It is a part of the strategy to reduce animal testing in laboratories.

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USP revised about thirty Ophthalmic Ointment Monographs

The United States Pharmacopeia, USP, revised about 30 Ophthalmic Ointment Monographs for clarification following the revision of General Chapter <771>  Ophthalmic Products - Quality tests. Read more about the revised USP Ophthalmic Ointment Monographs.

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Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 3

Once again, the American FDA has addressed a Warning Letter to an Indian Manufacturer of sterile medicinal products. Major and serious violations of GMP principles were identified at the Indian Manufacturer Emcure Pharmaceuticals Limited. Part 3 of this news will deal with the issue of insufficient documentation. You will find more information on the most important deficiencies in this Warning Letter here.

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European Competent Authorities publish GMP Non-Compliance Statements

Diverse European Authorities have issued GMP Non-Compliance Statements for Asian API and medicinal products manufacturers and one European manufacturer of medicinal products. These statements have been recently published on the EMA homepage.

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EU Draft regulation on the use of BPA in varnishes and coatings

The European Commission (EC) proposed a new Commission Regulation (EU) on the use of bisphenol A (BPA) in varnishes and coatings intended to come into contact with food. The draft regulation will also amend Regulation (EU) No. 10/2011 on plastic materials and articles to come into contact with food (Plastics Regulation) and lower the specific migration limit (SML) for BPA. Read more about the Draft Commission Regulation

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Implementation of ICH Q3D within the CEP Procedure

The EDQM has implemented the requirements of the ICH Q3D Guideline on elemental impurities also for the CEP procedure and has published a new policy document. Read more here about what has to be considered when applying or renewing a CEP, or for already existing CEPs with regard to elemental impurities in APIs.

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Recommendations from Health Canada for the Implementation of ICH Q3D

Recently in a notice, Health Canada has given its opinion about the implementation of the ICH Q3D guideline. Read more about which information on elemental impurities in applications for new marketing authorisations of medicinal products and OTC products, or in variation applications the Canadian Agency requires.

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Two new FDA Warning Letters for API Manufacturers in China

In June 2016, two API manufacturers in China received a Warning Letter from the FDA. Both companies had major deficiencies regarding data integrity. For instance, manipulations were found in HPLC analyses as well as in GC analyses. You will find more information on the current FDA Warning Letters for Chongqing Lummy and Shanghai Desano here.

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Is AQL Testing required within the 100% Visual Inspection?

One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspection of parenterals. The answer is: basically, "yes".

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EMA publishes Q&A Document on Production of WFI not obtained by Distillation

The revision of chapter 0169 of the European Pharmacopoeia will introduce in Europe as of April 2017 the possibility to produce WFI using other techniques than distillation. However, many questions are still unanswered like for example how the robustness of the new procedure compared to distillation should be demonstrated. The now published paper has been therefore highly anticipated. Read more here.

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Data Integrity - two new documents from PIC/S and EMA

Data Integrity is one of the hottest topics in regulatory activities at the moment. After the publication of draft documents by FDA in April 2016 and MHRA in July 2016, the PIC/S and the European Medicines Agency (EMA) followed on 10 August 2016 with two new documents. Please find here a short overview of the PIC/S draft PI 041-1 "Good practices for data management and integrity in regulated GMP/GDP environments" and the EMA  "Questions and Answers: Good Manufacturing Practices - Data Integrity".

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New FDA Guidance: How to not give Gifts to the Agency

FDA has published a new Draft Guidance for the Public and FDA Staff "Gifts to FDA: Evaluation and Acceptance". This is a rather interesting document.

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Rationale for the omission of the "well-closed" specification from USP general chapter <671>

In Pharmacopeial Forum 42(4) [Jun-Jul 2016] a stimuli article on the rationale for the proposed omission of the "well-closed" specification from the general chapter <671> Containers-Performance Testing has been published. Read more about the Rationale for the Omission of the Packaging and Storage Statement from USP-NF Monographs and the Omission of the "Well-Closed" Specification from Containers-Performance Testing <671>.

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How to perform Temperature Mapping

In a recent blog of the MHRA, the inspectorate looks at temperature mapping. It seems that "some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines".

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Refrigerated Medicinal Products: Things to consider

Based on the experience made in GDP inspections, the MHRA has published things to consider for the transportation and temperature management of refrigerated medicinal products.

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GDP: MHRA concerned about Qualification of Customers

In a new blog, the MHRA reminds companies to qualify their customers. This should be done similar to the qualification of suppliers.

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What does Brexit mean for the QP?

The decision of the U.K. to leave the EU has caused a high uncertainty throughout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information.

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