GMP News - Quality Assurance

15.06.22

Interpretation of 21 CFR 211.67 Cleaning of Equipment

The US-American GMP regulations for medicinal products are laid down in 21 CFR 211. Section 21 CFR 211.67 requires the establishment of and adherence to written instructions regarding the cleaning and maintenance of equipment. What is exactly meant by this?

08.06.22

MHRA introduces external consultants as Compliance Monitors in Companies

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project for a new Compliance Monitor Process. External consultants are being used for this purpose.

25.05.22

FDA plans Rating System for pharmaceutical Companies

The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.

18.05.22

EMA tackles the Issue of Remote Batch Certification

EMA has today published a draft question and answer document on the remote certification of batches by the Qualified Person (QP).

18.05.22

FDA Warning Letters for Products Containing CBD and Delta-8 THC

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

11.05.22

Classification of Packaging Changes

Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?

11.05.22

How many FDA inspections still take place in the EU?

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.

11.05.22

FDA Office of Pharmaceutical Quality publishes Annual Report 2021

The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?

10.05.22

Are You Recall Ready?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

04.05.22

Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published

The comment period for the draft revised ICH Q9 Guideline Q9 (Quality Risk Management) published in December ended in March. Now the feedback has been published.

04.05.22

Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

04.05.22

Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico

The USA FDA has issued a Warning Letter to a pharmaceutical manufacturer for failing to adequately address numerous deficiencies identified during an inspection.

04.05.22

Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

27.04.22

News on the various Mutual Recognition Agreements (MRAs)

The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.

26.04.22

FDA Warning Letter: No Quality Unit, No Thorough Investigations and No Stability Program

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

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Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach

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GMP News - Quality Assurance

Interpretation of 21 CFR 211.67 Cleaning of Equipment

MHRA introduces external consultants as Compliance Monitors in Companies

FDA plans Rating System for pharmaceutical Companies

EMA tackles the Issue of Remote Batch Certification

FDA Warning Letters for Products Containing CBD and Delta-8 THC

Classification of Packaging Changes

How many FDA inspections still take place in the EU?

FDA Office of Pharmaceutical Quality publishes Annual Report 2021

Are You Recall Ready?

Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published

Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico

Revised Technical Guide for Metals and Alloys

News on the various Mutual Recognition Agreements (MRAs)

FDA Warning Letter: No Quality Unit, No Thorough Investigations and No Stability Program

Recommended Event

Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach Learn How to Plan, Implement and Document Effectively Computer Validation Activities

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