GMP NEWS 2015

04.02.2015

USP Chapter <1790> Visual Inspection of Injections published

The long-awaited USP Chapter <1790> regarding the 100% visual control of injections has been issued in the Pharmacopeial Forum 41(1) for commenting. Read on.

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04.02.2015

Warning Letters in Fiscal Year 2014 - "Compounding Pharmacies" are Targets of the FDA

A large part of the Warning Letters sent by the FDA in fiscal year 2014 was addressed to "compounding pharmacies". Against this background, the statistics of the most frequent deviations highlight other focuses. Read more here.

More Warning Letters in Fiscal Year 2014 - "Compounding Pharmacies" are Targets of the FDA

04.02.2015

Falsified Results of Analysis at Indian Pharmaceutical Manufacturer

Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. In a further case the analysis results not complying with the requirements were deleted and the batch was released for the US market. Read more.

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28.01.2015

FDA publishes Guidance on cGMP Requirements for Combination Products

In one of our GMP Newsletter issues in April 2013, we reported about FDA's new GMP regulations for Combination Products (combination of a medical device with another product, e.g. a drug). These regulations came into force on 22 July 2013 as 21 CFR 4. The scope of these GMP provisions is relatively "light" and has been drafted in a kind of Question & Answer form. Now, the FDA has released the draft of Guidance on GMP requirements for Combination Products.

More FDA publishes Guidance on cGMP Requirements for Combination Products

28.01.2015

Elemental Impurities: USP announces the Date of Entry into Force of Chapters <232> and <2232>

A few days ago, the USP announced its approach to the revision of the General Chapters on metal impurities. Read more here.

More Elemental Impurities: USP announces the Date of Entry into Force of Chapters <232> and <2232>

28.01.2015

Change Control: New FDA Expectations for Equipment Changes

FDA has published a new Manufacturing Equipment Addendum for the SUPAC Guidelines (Scale-up and post-approval changes), describing the administration's expectations when assessing manufacturing equipment changes. Read more.

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28.01.2015

Leakages in Ampoules cause Recalls

There have been several recalls of sterile ampoules in Switzerland. The manufacturer stated a possible leakage as reason for the recall. Read more.

More Leakages in Ampoules cause Recalls

21.01.2015

CHMP adopts ICH Q3D Guideline as "Scientific Guideline"

The ICH Q3D Guideline recently published has been integrated into EMA's set of rules. The coming into force of the requirements laid down in this guideline now underlies defined deadlines. Read more here.

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21.01.2015

Product Tracing in the USA

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan over a ten year period dated from 2013 new requirements were defined in the USA which are to improve the traceability of prescription drugs within the supply chain. Now the start has been postponed by means of an FDA Guideline that was released already in December 2014. Read more.

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21.01.2015

FDA's new Quality Metrics Program to plan GMP Inspections

The US Food and Drug Administration has initiated a comprehensive new organisation of their inspection activities. One of the key elements of this initiative is the Quality Metrics Program. This program will throw a complete new light on the compliance status of each manufacturing site. Please read more about Quality Metrics in this GMP News.

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21.01.2015

Frequent Findings in Supplier Qualification

Supplier Qualification is a hot topic in inspections. Some examples of observations were published recently by the U.K. authority MHRA. Read more.

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20.01.2015

Human Cells, Tissues or Cellular- or Tissue-based Products - Exception from the Requirements under Part 1271

The US FDA published a draft guideline on Same Surgical Procedure Exception under 21 CFR 1271.15, related to human cells, tissues or cellular or tissue-based products. Read more here.

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20.01.2015

FDA finalizes Guidance for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

In December 2014, the Food and Drug Administration, Center for Biologics Evaluation and Research published the guidance on "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture". Read more here.

More FDA finalizes Guidance for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

20.01.2015

FDA Draft Guidance for initial testing for bacterial contamination of platelets published

With regard to Testing of Blood Platelets for Bacterial Contamination the US FDA has published a Draft Guideline. Read more here.

More FDA Draft Guidance for initial testing for bacterial contamination of platelets published

20.01.2015

FDA publishes Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products

The FDA has published a Draft Guideline with recommendations for human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff for the criterion of minimal manipulation. Learn more.

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15.01.2015

Draft: New Clinical Trial Rules in India

India's Central Drugs Standard Control Organization has published new draft regulations for clinical trials. One goal is to include a rule on compensation. Read more.

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15.01.2015

EMA publishes new GDP non-compliance report for wholesaler in Norway

In addition to GMP also GDP non-compliance reports are entered into the European Database EudraGMDP. The Norwegian Authority has issued a statement of non-compliance with GDP. Read more here.

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15.01.2015

EMA publishes Report on GCP Inspections

The European Medicines Agency (EMA) has published a summary report about the findings in GCP inspections conducted worldwide in the last years. Read more here.

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15.01.2015

GDP Implementation: Harmonisation needed?

Our article deals with the implementation of the EU requirements into national law of the EU Member States and uses Germany as an example. In Germany, GDP implementation is laid down in the Trade Regulation for medicinal products. Nevertheless, the regulation contains some ambiguous formulations which lead to problems for implementing GDP. Read more about the implementation of GDP in Europe.

More GDP Implementation: Harmonisation needed?

15.01.2015

Download 5 Chapters of the ECA/PQG Guide on Good Distribution Practice

The ECA Good Distribution Practices Group and the Pharmaceutical Quality Control Group have initiated a Working Group to develop an interpretation of the EU GDP Guideline. In order to better access the documents a new menu button has been added to the Members Area. Please read more here.

More Download 5 Chapters of the ECA/PQG Guide on Good Distribution Practice