Drug Development Consultant & Regulatory Consultant » manufacturing

Health Canada releases draft guidance on classification of observations for inspection of cells, tissues and organs establishments

damienbove — Wed, 08 Feb 2012 13:36:17 +0000

Health Canada has released a draft guidance to assist with companies become compliant with the safety of human cells, tissues and organs for transplantation regulations which came into force on 7 December 2007. The purpose of this regulatory initiative is to minimise the potential health risks to Canadian recipient of human cells and tissues and organs. And to ensure that such organisations remain compliant with the proposed regulations.

More information is available on the Health Canada website

Health Canada opens consultation on cleaning validation guidance

damienbove — Tue, 07 Feb 2012 13:33:54 +0000

Health Canada has opened the consultation process to provide guidance on issues and topics related to the validation of equipment cleaning the removal of contaminants associated with previous products, residues of cleaning agents as well as control of potential microbial contaminants. This guidance is for pharmaceuticals biologicals and radiopharmaceutical product manufacturers. The purpose of this guidance is to ensure that such manufacturers remain compliant with good manufacturing practice (GMP).

more information can be found on the Health Canada website

Health Canada publish new regulations on process validation for terminal sterilisation of pharmaceutical products

damienbove — Mon, 06 Feb 2012 13:31:03 +0000

The draft guidelines outlined in process validation: terminal sterilisation processes pharmaceutical products (GUI – 0074) applied to the validation of sterilisation of raw materials, packaging materials, and finished products pharmaceutical and veterinary drugs.

This guidance is to ensure that companies remain within compliance of good manufacturing practice (GMP)

More information is published on the health Canada website

FDA publish updated guidance on current good tissue practice (CGTP)

damienbove — Sun, 05 Feb 2012 13:26:30 +0000

The FDA is issuing this guidance to provide establishments that manufacture human cells, tissues, and cellular tissue-based products with recommendations complying with current good tissue practice (CGTP).

This is to ensure that all of these establishments can remaining compliance with 21CFR part 1271 subpart D and subpart E

FDA published guidance on the regulatory classification of pharmaceutical Co-Crystals

damienbove — Wed, 28 Dec 2011 09:42:34 +0000

This guidance is being developed for applicants of new drug application is an abbreviated drug applications in order to give them an insight into the agency’s current thinking on the classification of co-crystal solid-state forms. It also provides information about the data that should be submitted to support the appropriate classification and the regulatory implications of classification.

Full guidance given below

FDA produces guidelines on the use of nucleic acid test on pooled and individual donor samples to reduce risk of hep B transmission

damienbove — Tue, 27 Dec 2011 15:55:00 +0000

This guidance is being provided to blood establishments that collect whole blood and blood components for transfusion or other manufacturing. The FDA recommends the use of FDA licensed nucleic acid test to screen blood donors hepatitis B virus DNA. This guidance also provides recommendations for blood testing and disposition, Doner Management, methods of Donerrequalification and product labelling.

Full guidance provided below

FDA publishes guidance for industry on Q8, Q9 and Q10 (R4) questions and answers

damienbove — Wed, 14 Dec 2011 08:32:18 +0000

Since the Q8, Q9, and keep 10 guidance is were made final experiences implementing the guidance is in the ICH regions are given rise to requests for clarification. So the FDA has consolidated these requests into a structured questions and answers document that users should interrogate.

Q8 is associated with pharmaceutical development, Q9 is associated with quality risk management, and Q 10 is associated with pharmaceutical quality systems.

FDA updates guidance on questionnaires for screening blood donors

damienbove — Wed, 30 Nov 2011 11:02:46 +0000

The FDA has published draft guidance that recognises the abbreviated donor history questionnaire and accompanying materials as an acceptable mechanism collecting blood donor history information from frequent donors of blood and blood components that is consistent with the FDA requirements and recommendations.

The FDA is approved other abbreviated donor history questionnaires in the past and is brought blood donor questionnaires up-to-date in this respect.

excerpt from publication

full text here

This guidance recognizes the abbreviated donor history questionnaire and accompanying materials, version 1.3 dated August 2011, prepared by the AABB Donor History Task Force (referred to as “task force”), as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with the FDA requirements and recommendations. FDA has approved other abbreviated donor history questionnaires (aDHQ) in biologics license application supplements and may recognize other aDHQ and accompanying materials as acceptable in the future. We intend to make the aDHQ and accompanying materials (referred to as “aDHQ documents”) that we find acceptable available on the FDA website.
The aDHQ documents will provide blood establishments that collect blood and blood components (referred to as “manufacturers” or “you”) with a specific process for administering questions to frequent donors of blood and blood components1 (referred to as “frequent blood donors”) to determine their eligibility to donate. (In this guidance, the term “eligibility” refers to the donor suitability requirements described in Title 21 Code of Federal Regulations 640.3
(21 CFR 640.3)). Acceptable aDHQ documents are those documents that FDA has determined will provide manufacturers with one means of obtaining donor history information from a frequent blood donor to determine if the donor is eligible consistent with the requirements in 21 CFR 640.3.

Notification of authenticity of EMS certificates

damienbove — Sat, 26 Nov 2011 10:47:54 +0000

The European medicines agency has been informed that some health authorities in importing countries require further legislation or authentication of EMA product certificates.

in instances where any foreign agency has cast doubts the authenticity of the product certificate from the DMA, the DMA encourages these health authorities to request a duplicate of the DMA certificate directly from the MA. Requests can be made to the MA compliant Inspectorate sector via phone or e-mail or post. The request needs to include the reference number and the name and address of the person in Health Authority to and certificate can be sent, DMA will send the certificate directly to Health Authority free of charge.

full press release

The European Medicines Agency (EMA) has been informed that health authorities in some importing countries require further legalisation or authentication of the EMA certificates. The EMA supports the WHO’s view on the superfluous nature of authentication processes. In case of any doubt on the authenticity of already issued EMA certificates, the EMA encourages health authorities to request a duplicate of the EMA certificate directly from the EMA. These requests can be addressed to the EMA Compliance and Inspection Sector by fax +44 (0)20 7418 8595, by e-mail: certificate@ema.europa.eu or by post 7 Westferry Circus, Canary Wharf, London, E14 4HB, United Kingdom. The request has to include the reference number of the certificate(s) and the name and address of the person in the health authority to whom the certificate(s) can be sent. The EMA sends these certificates directly to the health authority free of charge.
If you have any comments or enquiries please send them by e-mail to certificate@ema.europa.eu for the members of the Certificates team to receive and act upon.

EMA publishes new information pack for certificates of medicinal products

damienbove — Fri, 25 Nov 2011 10:44:45 +0000

In support of the recent changes to the application procedure for certificates of medicinal products, EMA has published a new updated information pack on its website.

The CMP is being issued in the framework of the World Health Organisation certification scheme on the quality of pharmaceutical products moving in international commerce. And in accordance with this new procedure the European Union has changed its procedures and its application forms.

excerpt from publication

full text here

A Certificate of a Medicinal Product (CMP) is a certificate issued for a medicinal product by the authority granting the marketing authorisation. The purpose of these certificates is to certify the marketing authorisation status of the medicinal product and that the medicinal product is produced using acceptable Good Manufacturing Practice (GMP) standards.
CMPs are issued in the framework of the World Health Organisation (WHO) certification scheme on the quality of pharmaceutical products moving in international commerce. According to such a scheme, the CMP is intended for use by the competent authority within an importing country when the product in question is under consideration for a product licence that will authorise its importation and sale and when administrative action is required to renew, extend, vary or review such a licence.
The procedures for authorisation and, consequently, certification of medicinal products in the European Union (EU) are complex. The objective of this document is to provide a brief and easily understandable summary of the arrangements. More detailed information is available in the appropriate Community legislation1,2,3.