GMP News - Validation

12.08.15

The integrity of GMP data - part 2 of the new MHRA blog

In July 2015, the second MHRA blog on the theme of data integrity went live. This time, the focus is on designing systems properly. The ALCOA principles are considered to be very helpful. Read more about the MHRA Good Manufacturing Practice (GMP) Data Integrity blog part 2.

22.07.15

Integrity of GMP Data - New MHRA Blog!

In June 2015 the MHRA, UK, has started an online blog particularly on data integrity. From their perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. Read more about the MHRA Blog on Data Integrity.

02.04.15

New EU GMP Annex 15 Revision published - Valid as of 1 October 2015

In February 2014 the draft for the revision of Annex 15 was published. Compared with the currently valid version the changes were partly significant. Now the draft was published as final document and will be valid as of 1 October 2015. Read more about the Changes in Annex 15.

25.02.15

Detailed Requirements concerning the DOE in the Regulatory Submission Dossier: EMA's and FDA's Recommendations

The EMA has published together with the FDA a new question & answer (Q&A) paper at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Among others it contains the answer to the question "What level of detail should be considered for design of experiments (DOEs) in a regulatory submission?"

18.02.15

Requirements for Risk Analyses in the Regulatory Submission Dossier: EMA's and FDA's Recommendations

The EMA has published a new question & answer-(Q&A) paper together with the FDA at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Read the answers to the topic risk analysis here.

17.12.14

Frequent GMP Question: How many Signatures are required for Validation Protocols/ Reports?

As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? Which part do the Heads of Production and QA play for the signatures? Read more about the answers provided by the EU GMP Guide.

05.11.14

What are the EU GMP Requirements for the Validation of Excel Spreadsheets?

Everyone uses Excel Spreadsheets. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments. But what are the EU GMP requirements for the templates. Read more in our GMP News about Excel Spreadsheets.

08.10.14

WHO publishes second Draft on the Revision of its Process Validation Guideline

Comments to the first draft on the revision of the current process validation guideline (for non-sterile processes) from April 2014 have now flowed into the second one. This is obvious at one point or another. Read more.

10.09.14

Current FDA's Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

In cases of serious deviations from the GMP requirements, the US FDA issues Warning Letters to the companies concerned. In some current Warning Letters from 2014, significant GMP deficiencies with regard to IT topics can be found. Read on.

03.09.14

MHRA's Guidance for Software as a Medical Device (including Apps)

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has published a guidance for developers of "software as a medical device" = "stand-alone software". The text also expressly addresses "apps". Get the details here.

27.08.14

Current FDA's Warning Letters on IT Topics - Part 1: Medical Devices

02.07.14

Austrian QP Association (aqpa) publishes Comments on the Annex 15 Draft

The publication of the revised draft of the EU GMP Guide's Annex 15 is the opportunity for the EMA to get comments on it. The opportunity has been used by the Austrian QP Associaton (aqpa). Read more about the comments.

02.07.14

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

The FDA published its new Guidance for Industry (GfI) - "Electronic Source Data in Clinical Investigations" in September 2013. The Guidance defines the expectations of the FDA concerning electronic source data generated in the context of clinical trials. Find out more about this Guidance.

11.06.14

APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants

An APIC multinational working group has compiled a new guidance on cleaning validation with the title "APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Publication date is May 2014 and the document can be downloaded from the APIC website. Here you will find a summary description of the document.

04.06.14

ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper

When changing from paper-based to computerized systems and processes in the field of Good Clinical Practice (GCP), validating these systems is of critical importance, as inspectors are increasingly focussing on this facet of clinical trials. The ISPE GAMP R&D and Clinical Systems SIG has published a Concept Paper on the application of GAMP 5 validation principles to the GCP field. Read more here about the Concept Paper

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Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

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12-14 November 2024