Pharma GMP News of the Week: 26-September-2021
Period: September 19, 2021 to September 25, 2021
U.S. FDA published very useful guidance “Questions and Answers on Quality Related Controlled Correspondence – Guidance for Industry”
Date of publication: September 20, 2021
This questions and answers (Q&A) guidance provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in controlled correspondence submissions.
Questions covered in the guidance are:
a. Is it acceptable to use a bracketing approach for the manufacture of the exhibit batches of a generic drug product with multiple strengths produced from common bulk granulations (or blends)? Do all of these exhibit batches need to be put into the stability program?
b. If the reference listed drug (RLD) is a sterile injectable drug product packaged in an ampule, can the generic product be packaged in a vial?
c. Should a proposed generic ophthalmic drug product have the same cap color as the RLD when that color is not in line with the American Academy of Ophthalmology (AAO) recommendation?
d. If the dissolution method for a proposed generic drug product is not available in the FDA Dissolution Methods Database or in the United States Pharmacopeia (USP), can the Agency provide the dissolution method for the product?
e. How should a bacterial endotoxins test acceptance criterion be determined for the finished drug product?
f. Is it acceptable to omit bacterial endotoxin limits in the proposed specification for a topical ophthalmic drug product?
g. If an applicant intends to have more than one drug product manufacturing site in an abbreviated new drug application (ANDA), how many exhibit batches should be provided for each site?
h. If the generic drug product is a “for injection” (sterile lyophilized powder), can stability data for exhibit batches be generated using only one orientation?
i. If a product is packaged using blow-fill-seal technology and the container is composed of a single material, can stability data for exhibit batches be generated using only horizontal or upright orientation?
j. Should the three exhibit batches for a generic product be fully packaged in the proposed marketed packaging?
MHRA has updated information about Consultation on the future regulation of medical devices in the United Kingdom
Date of update: September 23, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has invited members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK).
MHRA wants to develop a future regime for medical devices which enables:
Improved patient and public safety;
Greater transparency of regulatory decision making and medical device information;
Close alignment with international best practice, and;
More flexible, responsive and proportionate regulation of medical devices.
Big News: New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders From the beginning of October 2021
Date of news: September 24, 2021
As per the EDQM website, from the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia monographs (CEPs) and CEP holders.
The news says that the communication with companies in the frame of their CEP applications will be streamlined, and e-mails or automatic notifications will be sent instead of letters in an increasing number of situations, such as reminders and acknowledgements of receipt of responses to deficiency letters and requests for revisions. Companies are therefore strongly advised to provide the DCEP with the name and valid e-mail address of a suitable contact person and to inform the DCEP whenever there are changes to this information.
This new tool will be used to ensure that documents related to CEP applications are shared securely. Applicants will no longer receive documents via e-mail but via the “EDQM DCEP Sharing tool”. Documents will be made available for download for 60 days maximum and will be deleted from the tool afterwards. Designated contact persons will receive a notification from the EDQM DCEP Sharing tool informing them of the automatic creation of their accounts and usernames and inviting them to choose a password. As indicated above, it is highly recommended to inform the DCEP immediately of any changes concerning the name or e-mail of the contact person.
The EDQM Database of Certificates of Suitability (CERTIFICATION Database) will display in real time the reasons why any CEPs are no longer valid (e.g. in case of suspension, withdrawal or expiry).
The implementation of this new IT tool may slow down CEP activities during the initial introductory phase.