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Quality Risk-Management Principles and PQRI Case Studies
A PQRI expert working group provides case study examples of risk-management applications. This article can be accessed form QRM-PQRI
New WHO Document on Transfer of Processes with detailed Guidelines for Analytical Method Transfer

The new WHO document on technology transfer also provides interesting and detailed indication for analytical method transfer. Click here to read the full news and to access the WHO document.
NEW US FDA guidance document on submission of summary Bio-equivalence data

This guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA’s requirements for the submission of bioequivalence (BE) data. FDA’s final rule on "Requirements for Submission of Bioequivalence Data" (the BE data rule) requires an ANDA applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval, including studies that do not demonstrate that the generic product meets the current bioequivalence criteria.2 All BE studies conducted on the same drug product formulation must be submitted to the Agency as either a complete study report or a summary report of the BE data.3 The amended regulations include a definition of same drug product formulation (section 320.1(g)).

This guidance provides information on the following subjects:

  • Types of ANDA submissions covered by the BE data rule.
  • Recommended format for summary reports of BE studies.
  • Types of formulations the Agency considers to be the same drug product formulation for different dosage forms based on differences in composition.
This guidance does not address which formulations the Agency considers to be the same drug product formulation based on differences in methods of manufacture. For more information click FDA guidance document.

EDQM - new draft general chapter - 2.9.47 entitled "Demonstrating of Uniformity of Dosage Units using Large Sample Sizes". - ABSTRACT
Recent developments in analytical technology have made possible the fast determination of unit content in a large number of dosage units from a batch using non-destructive analytical methods. These measurement techniques are often referred to as Process Analytical Technology (PAT). Using such methodology, a better understanding of the manufacturing process and a closer control of the drug product is obtained, as compared with the use of traditional analytical methods. The increased process control that is achieved by PAT is attractive both from the patient’s point of view (improved product quality) and from the industry’s point of view (increased production efficacy, less batch rejection).
Acceptable batch quality is demonstrated by compliance with the drug product specification. Usually, several of the tests of a specification refer to pharmacopoeial test methodologies and acceptance criteria. One such test is the harmonised Ph. Eur. general chapter 2.9.40. Uniformity of dosage units (UDU). To take full advantage of the increased batch control that is gained by PAT in general and a large sample size in particular, it should be legitimate to demonstrate batch compliance with UDU using other acceptance criteria than those applicable to small samples (n = 30). In this paper, a proposal for two new sets of test criteria is presented, applicable to sample sizes larger than 30. The proposal is intended for PAT applications, but is applicable also to traditional analytical methods. The test criteria would be stand-alone alternatives to the current criteria, and it would not be acceptable to re-evaluate a batch against these criteria if it already failed the UDU test for n = 30. The sampling plan has to be pre-defined and the sample should be representative of the batch.
In this draft, a larger sample size is proposed i.e.greater than 30. If larger deviation observed in the result then it shall be considered for acceptance due to large sample. For more details view draft here. 

Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3)

(2011/C 73/01)

This note provides guidance for minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.

This 3rd technical revision of the TSE (Transmissible Spongiform Encephalopathy) Note for Guidance has been undertaken to take into account advancement of science in the area of transmissible spongiform encephalopathies, as well as the evolving situation regarding Bovine Spongiform Encephalopathy (BSE) across the world.

For the classification of countries or regions according to their BSE risk, the revised Note for Guidance will make reference to the rules laid down by the World Organisation for Animal Health (OIE), replacing the previous GBR classification. Nevertheless, for countries that were classified according to the GBR criteria but not yet according to the OIE criteria, the existing GBR classification should apply, provided that there is no evidence of significant change in their BSE risk.

New criteria for the sourcing and processing of gelatin and bovine blood derivatives used in the manufacture of medicinal products for human or veterinary use have been introduced, as well as a new subsection on Peptones.

It replaces the previous revision of the Note for Guidance (EMEA/410/01 Rev. 2 published in the Official Journal of the European Union (C 24, 28.1.2004, p. 6)). The proposed date of application of this revised Note for Guidance is 1 July 2011.
To read the note click note for guidance
FDA draft guidance on 'Dedicated facilities'
This guidance describes the importance of implementing appropriate steps during the 20 manufacturing process to prevent cross-contamination of finished pharmaceuticals and active 21 pharmaceutical ingredients (APIs) with non-penicillin beta-lactam antibiotics. To read the guidline click draft of the new guideline.

ICH Q3C(R5) - Impurities - Guideline for residual solvents 
The introduction of isopropyl benzene(cumene) from class 3 to class 2 due to new toxicological data. Q3C guideline has been revised. You can find the new Guideline Q3C(R5) here 
Q3D: Impurities: Guideline for Metal Impurities - a new ICH Concept Paper
This new guidance is proposed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities. An additional Guideline Q3C was developed to provide clarification of the requirements for residual solvents. The proposed new Guideline Q3D would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification. click for concept paper
For USP stimuli article on Elemental Impurities

USP <1224> Transfer of Analytical Procedures
Earlier USP issued a stimuli article on 'Transfer of Analytical Procedures', based on comments received it finalises the procedure and issused USP general chapter <1224>. This chapter describes the procedure for transfer of analytical procedure from one laboratory to another laboratory either within the organisation or different organisation. This procedure can be downloaded from pharmacopeial forum.
The only difference between stimuli article and general chapter is a risk based approach suggested for type and extend of transfer activities.
Process validation - FDA guidance for industry released - Revision 1
This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.
This guidance has been prepared by the Division of Manufacturing and Product Quality, Center for Drug Evaluation and Research (CDER), in cooperation with CDER’s Office of Pharmaceutical Sciences, the Center for Biologics Evaluation and Research (CBER), the Office of Regulatory Affairs (ORA) and the Center for Veterinary Medicine (CVM) at the Food and Drug Administration.
The lifecycle concept links product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This guidance supports process improvement and innovation through sound science.
To download click process validation

FDA issused a final guidance document on ANDA's  - Impurities in Drug Products
Earlier US FDA issused the guidance on impurities on drug substance now issused for drug product also.
US FDA issuing this final guidance for the following reasons:
  1. To update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products (thresholds and procedures) in ANDAs in conformance with the revision of the guidance for industry on Q3B(R) Impurities in New Drug Products.
  2. To remove those sections of the 1998 draft guidance containing recommendations that are no longer needed because they are addressed in the more recent Q3B(R) (see the list below).
The Q3B(R) was developed by the International Conference on Harmonisation (ICH) to provide guidance on impurities in drug products for new drug applications (NDAs). However, the Agency believes that many of the recommendations provided on impurities in drug products also apply to ANDAs. Please refer to the following specific sections in the Q3B(R) for these recommendations:
  • Section I, Introduction
  • Section II, Rationale for the Reporting and Control of Degradation Products
  • Section III, Analytical Procedures
  • Section IV, Reporting Degradation Products, Content of Batches
  • Attachment 1, Thresholds for Degradation Products
Download guidance document ANDA's-Impurities in Drug Products

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