GMP NEWS 2017

Annex 16 QP Certification: important Questions and Answers

What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of the questions in conjunction with the "Certification by a Qualified Person and Batch Release" being now answered by an inspectorate.

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Pro Generika - New Shareholder in the securPharm Manufacturer Database

On 15 March 2017, a common press release was published to announce the joining of Pro Generika e.V. as shareholder in the ACS PharmaProtect GmbH (ACS). ACS was founded in 2012 with the aim of developing and operating the manufacturer database in Germany. Read more about the joining of Pro Generika e.V. in the ACS PharmaProtect GmbH.

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MHRA's Interpretation of Cross Contamination & PDEs

The British inspectorate MHRA has recently published a comprehensive document that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept must be applied. One essential element of that concept is EMA's Q&A Paper describing when a product should be classified as highly active. This Question & Answer Paper can be commented on until the end of April 2017. Read more here.

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PIC/S statement to European Commission's ATMP GMP Guideline

The PIC/S published a harsh letter to the European Commission relating to their draft guideline on GMP for Advanced Therapy Medicinal Products (ATMP).

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Ongoing developments in the field of ATMP

Beginning of February, the European Medicines Agency (EMA) published new information about Advanced Therapy Medicines and how to get to an increased ATMP development and patient access.

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Feedback of the EQPA IMP Working Group on the Commission Delegated Regulation on GMP for IMPs

The IMP Working Group within the European QP Association sent in their comments to the EU Commission on the Commission Delegated Regulation on GMP for IMPs, incuding some recommendations.

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Supplier Audits: Expectations clarified by Inspectorate

What the inspectorates expect regarding supply chain traceability and the role of the QP has been pointed out in a recent blog issued by the British MHRA.

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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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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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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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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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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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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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