current Good Analytical Laboratory Practices (cGALP)

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CEP suspended or withdrawn due to inspection of manufacturing sites.
Concept paper on Storage Conditions during Transport
 
This paper is concerned with challenges related to the maintenance of appropriate transit conditions during transport as products move through all stages of the manufacturing and wholesale distribution system from active substance through the wholesale distribution system to ensure that patients and animals receive safe and efficacious medicinal products.
 
From a product’s perspective, transport is a mobile form of storage but where there are weaker controls than storage in fixed sites – therefore similar levels of controls should exist. Compliance at all stages of manufacture and distribution becomes more important as the number of transport stages increase, including transport (i.e. import) into the EU. Several examples have been seen where sea-freight significantly exceeds 30 days. Any increases in the length of time and/or the climactic challenge at each stage will also impact on compliance. It is also increasingly difficult to be aware of and to assess the cumulative effects of adverse incidents at different stages.

Many sites of manufacture are now located in tropical zones and/or where transport infrastructure may be difficult. Therefore the challenges arising from transport between such sites and from these sites to the EU may take finished products, or their earlier stages of manufacture, outside of the conditions defined in the EU Marketing Authorisation for storage of the product. Also, the risk of freezing during transport and the effects on the products should be considered.

It is important to understand the susceptibility of different products at the different stages and whilst the principles of quality risk management would be applied on a product by product basis at each stage of manufacture and transport would be expected, the reality is that different products and different product stages are frequently co-shipped. It is therefore evident that a simple set of readily understood general rules should apply to transit conditions to reduce this complexity and risk of error.

Although widely acknowledged, there is no explicit requirement for the need to conduct transport studies under worst case conditions and no requirement for routine monitoring during transport.
Primer for GLP & GMP for Analytical Lab - Agilent
Top ten deficiencies found during first assessment of new applications from October to December 2009 - EDQM
 
This document is a summary of the main questions resulting from the first assessment of new applications for Certificates of Suitability (CEP) for chemical purity. It is based on the content of 108 deficiency letters sent to the applicants on applications treated from October to December 2009.
 
The Top 10 questions are listed below with additional recommendations regarding EDQM requirements added. By including these recommendations - together with the requirements described in the EDQM Guideline "Content of the dossier for chemical purity" PA/PH/CEP (04) 1 (current version) which is available on our website - applicants can improve the quality of their dossiers with a view to facilitating and speeding up the granting of their CEP.
 
TOP 1 (3.2.S.2.2) / (3.2.S.2.3): Redefinition of starting material
TOP 2 (3.2.S.2.3): Absence of discussion on the carry-over of impurities/by-products from key materials
TOP 3 (3.2.S.2.3): Absence of discussion for Class 1 solvent as contaminant of another solvent
TOP 4 (3.2.S.3.2): Genotoxic impurities
TOP 5 (3.2.S.4.4): Absence of comparison of the quality of the final substance obtained with starting materials from different suppliers
TOP 6 (3.2.S.2.3): Incomplete specifications for the declared starting materials
TOP 7 (3.2.S.4.3): Suitability of the monograph to control the impurity profile of the final substance
TOP 8 (3.2.S.6): Specification for container closure system
TOP 9 (3.2.S.3.2): Compliance with the requirements of the Ph. Eur General Monograph 2034: limit for unspecified impurities
TOP 10 (3.2.S.2.3): Solvent recovery
For more information click the weblink
How to do document - New revised APIC guide - GMP for API
 
It describes the intrepretation of ICH Q7 with revision in quality management, personnel & agents,brokers,traders,distributors,repackers and relabellers - Version 6.
 
Example of Quality Risk Management (QRM) Implementation by PIC/S
An informal working group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in industry. For download example
EU GMP Guide chapter-7 revised - Outsourced activities -contract manufacturer and analysis
Chapter 7 of the EU GMP Guide "Contract Manufacture and Analysis" has been revised and was published on the GMP-information site of the European Commission on 9 November 2010.
Reasons for changes: in view of the ICH Q10 guideline on the Pharmaceutical Quality System, Chapter 7 of the GMP Guide has been revised in order to provide updated guidance on outsourced GMP regulated activities beyond the current scope of contract manufacture and analysis operations. The title of the Chapter has been changed to reflect this.
WHO guideline on Quality Risk Management
This guideline will align with the general framework described within other current international papers on this subject.
 
Principles of quality risk management- Four primary principles of QRM are:

•the evaluation of the risk to quality should be based on scientific knowledge and
ultimately link to the protection of the patient;
• QRM should be dynamic, iterative and responsive to change;
• the level of effort, formality and documentation of the QRM process should be
commensurate with the level of risk; and
• the capability for continual improvement and enhancement should be embedded in the QRM process.
Change in ICH classification of residual solvent - Cumene(Isopropyl Benzene) - From class 3 to class 2
 
Cumene is listed in the ICH Q3C(R4) guideline in class 3. A revision to the ICH Q3C(R4) guideline is proposed in which it is recommended that cumene be placed into class 2 to take account of new toxicity data.
 
To go through draft guideline and send comment click Draft guideline
Out-Of-Specification (OOS)
Investigation is must for any product failures to find out the root cause and Corrective And Preventive Action(CAPA). USFDA come up with definite guidance on this subject. This guideline helps to handle OOS data and procedure for investigation. For more information refer the below link. FDA Guidance - OOS
Out-Of-Trend(OOT) Analytical Results
 
OOT means an analytical result which fall with in the specification limit but does not follow with in the trend or unexpected result. Normally any analytical result which fall in Out-Of-Specification requires a detailed investigation to find a root cause failure and folowed by a currettive And Preventive Action(CAPA).
 
Though regulation demands investigation to be completed with in thirty days but most of the cases industries fails to complete the investigation with in stipulated period to find root cause. Meanwhile its end up with few more failures. To avoid such things happen the current practice starts investigation when results appear to be out-of-trend.
 
The following links help to know more about OOT
 
 
Revised Annex 13 on Investigational Medicinal Products (IMP) coming into operation 
The European Commission has published on the EudraLex - Volume 4 webpage the new Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice. The new Annex is coming into force in July 2010.
 
Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7 
The European Commission published a revised Part 2 text on GMP for APIs which will enter into force by 31 July 2010.
A template for API quality agreement 
This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a guide for drafting a Quality Agreement relating to the manufacture and release of substances regulated by the Food and Drug Administration. The template is based on the collective experience of industry members. This can be downloaded by clicking Quality agreement template 
WHO released draft guidance for production and control of specified starting material
 
Specified starting material means any substance which is primarily or mainly used as a starting material for the production of an API, but which could be used directly as an API.
 
This guideline is intended to assist applicants or MA holders in assessing the required level of quality of “specified starting materials” that will be used for the manufacture of an API. It is also intended to help API master file holders (APIMF) in the compilation of their APIMFs
 
The control of the “specified starting materials” should be designed to detect isomeric or other impurities which are potentially reactive and could be carried through to the final product of the synthesis.
 
For more information click WHO guideline
 
 
 
 
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