Pharma GMP News of the Week July 18 2021

Pharma GMP News of the Week: 18-July-2021

Period: July 11, 2021 to July 17, 2021

WHO has released draft guideline on Good Manufacturing Practices for investigational products:

Document Number: Working document QAS/20.863/Rev1

Month of publishing: July 2021

World Health Organization (WHO) Prequalification Team – Inspection Services (PQT INS) raised the urgency for a revision of the WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans. The Fifty-fifth Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) concurred with this proposal.

The objective of this update is to bring the guideline in line with current expectations and trends in good practices and to harmonize the text with the principles from other related international guidelines. Investigational products are used for testing purposes; as a reference in clinical trials and field trials; as a placebo; for an unauthorized indication; and to gain further information about the authorized form. In some cases, marketed products which have been re-packaged or modified in some way, are used for investigational purposes.

Download the draft guidance

Source: WHO guideline

PICS released guideline on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1)

Document Number: PI 055-1

Date of publishing: 15 July 2021

On 15 July 2021, PIC/S announced adoption of guidance on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1). This guidance for inspectorates, which has been prepared by the PIC/S Working Group on Inspectors

Risk Assessment covers announced GXP inspection of national sites. This needs to be completed during the inspection planning phase, in consultation with the site to be inspected, prior to the inspection taking place. The site must confirm that the necessary measures identified in the risk assessment will be implemented Consideration should also be given to Covid testing of Inspectors / Investigators pre and post inspection and may be requested by some sites.

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PICS released guideline on “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management” (PI 054-1)

Document Number: PI 054-1

Date of publishing: 15 July 2021

This document addresses two fundamental and inter-related elements of the PIC/S GMP Guide – PQS effectiveness and the management of changes. It provides practical guidance for GMP Inspectors in these areas, and the implementation of that guidance has the potential to ultimately lead to the more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation.  This serves the interest of patients and animals.

In addition to providing guidance for GMP Inspectors, the document provides the pharmaceutical industry with a ready-made solution for addressing a key aspect of ICH Q12 – the requirement to have an effective PQS that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place. 

The guideline also covered important aspects and examples of Change Review and effectiveness review with headings “Prior to change closure” and “Prior to or after change closure”.

Download the guidance


WHO has released draft guideline on WHO good practices for research and development facilities of pharmaceutical products:

Document Number: Working document QAS/20.865/.Rev1

Month of publishing: July 2021

In view of the need for the development of health products, including the research and development for the treatment of COVID-19 therapies, the World Health Organization (WHO) Prequalification Inspection Services Team (PQT INS) raised the urgency for the development of life cycle appropriate good practices text to address the manufacturing of developmental batches, pilot batches and the sequential stability data that are submitted in product applications (dossiers) for marketing authorization and the prequalification of medical products.

There is currently no other specific WHO guideline which addresses this matter. The data collected from these batches influence the aspects of the product i.e. stability; process validation; and analytical method development and validation.

This guideline is specifically applicable to research and development facilities of pharmaceutical products procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, validation, quality control laboratory activities such as stability testing and development, and validation of cleaning procedures.

The main focus of this document is to provide for GxP in the production and control of pre-clinical and not for human use batches, manufactured in pharmaceutical formulation and development facilities, where these are directly supporting; for example, shelf life claims, animal studies or validation activities. The principles described in this document may be applied in facilities where other products, such biopharmaceutical products, vaccines and medical devices, are manufactured.

Download the guidance

Source: WHO guideline

Implementation of the European Pharmacopoeia Supplement 10.6 and Notification for CEP holders to update their applications according to the revised monographs

Date of announcement: July 13, 2021

Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the instructions given below.

According to Directives 2001/83/EC and 2001/82/EC, as amended, it is the responsibility of the manufacturer to comply with the current version of a Ph. Eur. monograph, and therefore to update the specification when a revised monograph is issued. In addition, the European Directorate for the Quality of Medicines and HealthCare (EDQM) ensures that CEPs refer to the most recent version of a Ph. Eur. monograph at any time.


CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3

Date of announcement: July 15, 2021

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3. The lists of the substances affected by these revisions and for which CEPs have been granted.

Users can register for free for the access to Pharmeuropa on the EDQM website Pharmeuropa, Pharmeuropa Bio & Scientific Notes.


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