GMP NEWS 2017

Use of the Data Matrix Code - Which Regulations apply to Coding?

securPharm has released coding regulations by means of the Data Matrix Code. The document also addresses the automated identification of medicinal product packages in the pharmaceutical supply chain. In addition, requirements about clinic packs are also available. Read more about the securPharm regulations on the coding of medicinal products subject to mandatory verification.

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EMA Paper on Dissolution Specification for Generic Products published

EMA's "Reflection Paper" from May 2016 on dissolution testing for immediate release of oral dosage forms deals with the specific requirements concerning the tests which should be taken into consideration when submitting applications for a marketing authorisation. Get the details about EMA's Reflection Paper on dissolution specification.

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USA and EU adopt Mutual Recognition Agreement - Does it mean the End of FDA Inspections in Europe?

On 2nd March 2017, the US FDA and the EU (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognize GMP inspection systems. As a consequence, the GMP Compliance of a site is reviewed by the respective inspection authority. Afterwards, the FDA can use EU inspection results and vice-versa. Read more about the FDA//EU MRA Agreement.

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Inadequate Cleaning and Batch Release in spite of Incomplete Quality Control - Warning Letter to an Indian API Manufacturer

During the inspection of an Indian API facility, FDA investigators found that basic requirements for GMP-compliant manufacturing weren't complied with. This led to a Warning Letter. Read more about the detailed deficiencies in cleaning and validation of test methods, and the maintenance of analytical devices.

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How to perform Cleanroom Monitoring

The premises dedicated to the manufacture of medicinal products have to be monitored. Depending on the type of product to manufacture and whether it is a sterile or a non-sterile medicinal product, the requirements for cleanroom monitoring are more or less demanding.

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Sterile plastic containers for human blood and blood components

A draft for Ph. Eur general chapter 3.2.3. Sterile plastic containers for human blood and blood components has recently been published for comments in Pharmeuropa. It is proposed to delete the abnormal toxicity test (2.6.9) (ATT) from the Tests section.

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New GDP Rules in Russia - what you need to know

From 1 March 2017 there are new GDP rules valid in Russia . All pharmaceutical companies distributing to Russia should be aware of the new Russian GDP regulations.

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What are the regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain"?

What do storage requirements like, for example "ambient", "room temperature" and "cold chain" exactly mean? Worldwide, there are different definitions for these storage requirements.

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The GMP/GDP Interface: When the Inspector comes

Storage facilities are not only a hot topic in GDP inspections. GMP inspectors also make observations in these areas, as some examples show, which were published by the U.K. authority MHRA.

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Quo vadis Cleaning Validation in Annex 15?

In the draft revision of Annex 15 of the EU GMP Guide (Validation / Qualification) there were significant changes in the chapter on cleaning validation threshold determination. Which of these changes will still to be found in the final document? Read on here.

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Proposed Revision of the USP Chapter on Spectroscopic Methods

In the Pharmacopeial Forum of the USP the revision of the General Chapter <197> on Spectrophotometric Identification Tests is proposed. As part of the revision, the sections NIR and RAMAN would be newly included. Get more information about the planned update of the USP on identification tests.

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Delegated Regulation on the Anti-Counterfeiting Directive - New EU Requirements and State of Implementation

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission has released version 5 of its Questions and Answers on safety features and the German initiative securPharm has just published the Status Report for 2017. Read more about the SecurPharm Status Report 2017 and about the EU's Q&A document on safety features.

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What are the current Rules for Supplier Qualification?

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for supplier qualification?

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GMP Requirements for Certificates of Analysis (CoA)

Certificates of Analysis (CoA) have to be issued for excipients, APIs, packaging materials and finished products. Regarding those certificates, there are a number of guidelines. A closer look at these guidelines shows that there are several regulatory requirements which are often unknown. Read more about GMP/FDA compliant Certificates of Analysis (CoA).

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Sterile Manufacturer receives Warning Letter from US FDA

Following an FDA inspection, a manufacturer of sterile medicinal products in the UK has received a Warning Letter due to serious violations of GMP. As often in such cases, the inspection was preceded by another one where GMP deviations had been observed but to which the company had responded insufficiently. Read more about this Warning Letter here.

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WFI obtained by non-distillation methods - What are the Next Steps?

The European Pharmacopoeia's revised monograph 169 on water for injection (WFI) will become effective by the 1st of April 2017. For the first time in Europe, a monograph will allow the production of WFI with other methods than distillation. But there are still unanswered questions, e.g. how to deal with HPW systems which have been already producing water with WFI quality. Read more about the revision of the Monograph on WFI.

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New FDA Guidance: When is a Product considered "Suspect"?

In December 2016, the FDA published a guideline setting specific requirements on how trading partners can identify suspect products and inform the FDA about them. Read more information about FDA's current document "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" here in this News.

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Counterfeit Medicines in the Legal Supply Chain

The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls - e.g. due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Read more about it here.

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First Warning Letter Citation of new FDA Guideline on Contracts

After the Food & Drug Admininstration (FDA) published its final Quality Agreements Guidance end of last year, we now find the first citations in Warning Letters.

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Inspection Findings in Supplier Qualification and Contracting

Supplier Qualification and Contracts are a hot topic in inspections. Some detailed examples of observations were published recently by the U.K. authority MHRA.

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