Tuesday, November 2, 2010
Monday, November 1, 2010
“Qualification” means “a conclusion that within the stated context of use, the results of assessment with a DDT can be relied upon to have a specific interpretation and application in drug development and regulatory decision-making.”
In the draft guidance, FDA proposes stages for the qualification process, including consultation and advice with CDER (e.g., letter of intent, briefing, meeting, investigation), and review for the qualification decision. The agency intends to make public its information regarding qualified DDTs.
Tuesday, October 19, 2010
Chinese State Food and Drug Administration Proposed Route of Registration for APIs, Excipients and Auxiliary Materials
· The drug product manufacturer is the entity responsible for the quality of component materials used in the drug
· Scope covers drugs registered for sale in China, apparently not APIs or excipients which are made for export only
· Clinical investigational materials are not addressed in this document
· Audit reports from the drug product manufacturer audit of their suppliers mentioned in this document must be submitted in the filing
Sunday, October 10, 2010
On September 15, 2010 EMA and FDA formally extended their existing confidentiality agreements for an indefinite period. This agreement allows sharing of inspection reports and other non-public information between the agencies.
On September 24, 2010, FDA and ANVISA signed a confidentiality agreement that permits sharing of non-public information. This is the first confidentiality agreement between the two regulatory agencies, and acknowledges Brazil’s rising importance as a pharmaceutical market and supplier and ANVISAs rise as a regulatory agency.
To read the agreements between agencies write to me i will be sending you the same agreements
Friday, October 8, 2010
Wednesday, October 6, 2010
These operation-related appendices served as the basis for the creation of a GAMP GPG (Good Practice Guide) "A Risk-Based Approach to Operation of GxP-Computerized Systems - A Companion Volume to GAMP®5" published at the beginning of 2010. GPGs are based on the GAMP®5 and focus on specific areas within the life cycle (e. g. testing) or on particular IT systems (e. g. MES systems).
The structure of this GPG follows, as far as this is possible, the structure of the operation-related GAMP®5 appendices.
01. Introduction 02. Overview of the Operation Phase03. What Organizations Should Do04. Process Relationships05. Handover06. Establishing and Managing Support Services07. Performance Monitoring08. Incident Management09. Corrective and Preventive Action10. Operational Change and Configuration Management11. Repair Activity12. Periodic Review13. Backup and Restore14. Business Continuity Management15. Security Management16. System Administration17. Data Migration18. System Retirement, Decommissioning, and Disposal19. Appendix 1 - RACI Roles and Operational Processes 20. Appendix 2 - Mapping of Operational Processes to ITIL® and COBIT®21. Appendix 3 - List of Control Records22. Appendix 4 - References23. Appendix 5 - Glossary
On balance one can say that the GMP-regulated environment places more and more emphasis on the operational phase of computerised systems. As a complement to the GAMP®5 Guide, the GAMP GPG "A Risk-Based Approach to Operation of GxP-Computerized Systems - A Companion Volume to GAMP®5" gives excellent guidance for daily practice.
This is pasted from GMP Compliance website
Tuesday, October 5, 2010
Friday, October 1, 2010
Maintenance of Active Pharmaceutical Ingredient (API) and other sites named on marketing authorisations
Marketing and manufacturing authorisation holders are reminded that as all sites named on approved marketing authorisations (MAs) can be used for the activity they have been registered for without further variation or provision of evidence of Good Manufacturing Practice (GMP) compliance to the MHRA, it is important that all named sites are fully maintained as approved suppliers and thus available for use.
Through its inspection programme, the MHRA has encountered numerous examples of API manufacturing sites that are named on marketing authorisations but are not currently used and not fully maintained as approved suppliers. In some cases such API sites may never have supplied API for marketed product. This can also apply to other sites eg drug product manufacturing, importation or batch release sites.
Therefore in order to clarify MHRA expectations the following guidance is provided:
All API manufacturing sites named on UK marketing authorisations (product licences) must be actively maintained as approved suppliers (in line with EU GMP expectations).
The MHRA regards all API manufacturers that are registered on UK marketing authorisations to be approved to supply without further notice and with immediate effect; sites without proven documented GMP compliance status cannot be regarded as an effective back up supply source of starting material.
As a minimum, and in order to comply with EU directives on the use of GMP compliant APIs, the supplier approval process must be supported by evidence of effective GMP compliance of the API manufacturing site(s). As per European Medicine Agency (EMA) guidance it is expected that this will be confirmed via audit of the API manufacturing site by or on behalf of the relevant manufacturing authorisation holder. Audits should have been conducted at intervals not exceeding three years, by persons with appropriate training and experience, to confirm the current GMP status of the site.
Any API manufacturer listed on a UK marketing authorisation that has not been maintained as an approved supplier does not meet the EU requirements for starting materials to have been manufactured in compliance with EU GMP requirements.
The MHRA can inspect API sites named on marketing authorisations at any time where GMP compliance status is unknown or suspected to be deficient. Confirmation of non-compliance can result in regulatory action being taken by the MHRA.
Companies not wishing to maintain back up API manufacturers to GMP requirements should remove them from marketing authorisations by submission of a Type 1A variation change code A.7.
The MHRA will continue to monitor compliance with this guidance through its inspection programme of MIA holders and as necessary by inspection of marketing authorisation holders.
In addition to reviewing the approval status of API manufacturers named on marketing authorisations, holders are also requested to remove any other sites that are no longer used/maintained eg drug product manufacturing, importation or batch release sites etc by use of a Type 1A variation, change code A.7.
Thursday, September 30, 2010
It is clearly stated by the MHRA that in future all inspections will cover QRM processes as they are required by the EU GMP Guide Part1 Chapter 1 and Annex 20. Inspectors will have a look at ICH Q10 elements like
A company should therefore have procedures in place that embody quality risk management, including descriptions on how the management system operates. A risk register (or similar document) should list and track key risks. The respective processes should be reviewed by the management. In the FAQs also the key attributes are listed that should be observed.
For more details please also see the FAQs.
Compiled by Wolfgang SchmittOn behalf of the European Compliance Academy (ECA)
In July, the Institute of Environmental Sciences and Technology announced that ISO 14644-9 "Cleanrooms and associated controlled environments—Part 9: Classification of surface cleanlinesss by particle contamination" is now a Final Draft International Standard (FDIS).
This revison of the document should make it more efficient and easy to understand for the user. It describes the classification of particle contamination levels on solid surfaces in cleanrooms and associated controlled environment applications and should build the new standard in this field.
Part 9 provides a classification for the determination and designation of surface cleanliness levels based on particle concentrations and it also lists some methods of testing, as well as procedure(s) for determining the concentration of particles on surfaces.This part of ISO 14644 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 μm and 500 μm.
Surface cleanliness depends on material and design characteristics, stress loads (complexity of loads acting on a surface), and prevailing environmental conditions, along with other factors. Measurement methods of the classification should be adapted for surface characteristics (such as porosity, roughness, electrostatic charge, and surface energy). Recommendations on testing and measuring methods as well as information about surface characteristics are given in informative annexes.
It does not cover issues like requirements for the cleanliness and suitability of surfaces for specific processes, procedures for the cleaning of surfaces, material characteristics; references to interactive bonding forces or generation processes that are usually time-dependent
process-dependent; selection and use of statistical methods for classification and testing; other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.
The IP Commission is examining this issue and would come out with proper solution in consultation with competent authority and stakeholders.
Effective Date of IP 2010 - Amended
The Commission has been approached/received representations from stakeholders showing their inability to implement the changes prescribed in IP 2010 from 1st September, 2010. The matter was put in the 20th Scientific Body meeting held on 21st August, 2010 at IPC, Ghaziabad.
The new effective date of IP 2010 is from 1st December, 2010 onwards.
(Dr. G. N. Singh)
The arrangements allow both agencies to exchange confidential information as part of their regulatory and scientific processes. The types of information covered relate to scientific advice, orphan drug designation, pediatric development, GMP and GCP, inspection planning and reports, marketing authorization procedures and subsequent changes to the marketing authorizations, together with post-marketing surveillance.
The types of medicines covered are those subject to evaluation or authorized under the centralized procedure, as well as medicines that are authorized at national level by EU member states and that are subject to official European Community arbitrations and referrals.
Cooperation between the two agencies has been increasing significantly during the past few years. Only last month, the agencies issued a call for candidates to take part in a joint GMP inspection pilot programme. In March, the agencies also agreed to accept a single orphan drug designation annual report.