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Tuesday, May 28, 2019

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Friday, May 10, 2019

Pharmacology of ACE inhibitors , mechanism of action , uses and side effects

ACE INHIBITORS


Introduction

ACE inhibitors are among the most widely prescribed cardiovascular medicines.
The ACE inhibitors are -
  • Raipril
  • Lisinopril
  • Perndoprol
ACE inhibitors are used in the treatment of the following conditions :
  • Hypertension - ACE inhibitors reduce the risk of serious cardiovascular events, such as heart attack and stroke. they may be used first or second line, usually usually in combination with another drugs.
  • Ischemic heart disease - as with hypertension, the purpose of ACE inhibitors is to reduce the risk of heart attack and stroke.
  • Chronic heart failure - used for the symptomatic treatments of heart failure, improving overall prognosis for the patients.
  • Diabetic nephropathy - ACE inhibitors can be used to prevent nephropathy from progressing in diabetic patients. They may also be used for chronic kidney disease ( with proteinuria ) to reduce proeinuria.
ACE inhibitors are, then , an important class of cardiovascular medicines that play a significant clinical role hypertension, heat disease and kidney comlications.

Mechanism of action

The fundamental mechanism of ACE inhibitors pharmacology involve blocking the effect of ANGIOTENSIN CONVERTING ENZYME. The ACE enzyme is is predominantly found on the surface pulmonary and renal epithelia.

This enzyme is responsible for converting angiotensin I (ATI) to angiotensin I (ATI) Angiotensin I is itself produced from

angiotensinogen, a globular protein released from the liver in response to renin release from the kidney.

To summarize:
Renin is released from the juxtaglomerular apparatus of the
kidney in response to electrolyte and/or water imbalances in the body:
Low sodium levels
Low blood pressure
Decreased blood volume

 Renin cleaves angiotensinogen intoATI.
Angiotensin-converting enzyme turns ATI into ATII.

Why is reducing angiotensin II levels important ?
  • ATII stiulates the release of aldosterone from the adrenal cortex.
  • In turn, aldosterone promotes reabsorption of sodiu and chloride ions, increasing water retention. During this process, potassium is also excreted.
  • Vasoconstriction; increasing blood pressure.
  • ADH secretion from posteriour lobe of the pituitary gland, prooting water retention from the collecting ducts.
ACE inhibitors, by preventing produvtion of ATII, has the following effects :

  • Prevent aldosterone release from the adrenal cortex.
  • Elimination of sodium ions ( and increased water loss ) from the kidney.
  • Potassium ions are retained.
  • Consequent reduction in blood volume and blood pressure
ACE inhibitors pharmmacolgy is dependent upon the cessation is dependent upon the 

Tuesday, May 7, 2019

ICH Guidelines ( easy notes )


ICH

International council for hormonisation of technical
Requirements for pharmaceuticals for human use

It is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.
Hormonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health.
 ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines.

ORGANISATION OF ICH


Process of Harmonisation


ICH harmonisation activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision Procedure and Maintenance Procedure, depending on the activity to be undertaken. The development of a new harmonised guideline and its implementation (the formal ICH procedure) involves 5 steps

·         Consensus building

·         Confirmation of consensus on the Technical Document

(b) Endorsement of draft Guideline by Regulatory Members

·         Regulatory consultation and discussion

                   Stage I - Regional regulatory consultation
                   Stage II - Discussion of regional consultation comments
                   Stage III - Finalisation of Step 3 Experts Draft Guideline

·         Adoption of an ICH Harmonised Guideline

·         Implementation


ICH Guidelines
The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.



QUALITY GUIDELINES
The quality guidelines consists of chart of guidelines Q1 to Q14 which are described bellow :

Q1A – Q1F STABILITY

Q1A (R2)          Stability testing of new drug substances and products
                          This Guideline provides recommendations on stability testing protocols including
                                temperature, humidity and trial duration for climatic Zone I and II. Furthermore, the revised
                                document takes into account the requirements for stability testing in Climatic Zones III and
                                 IV in order to minimise the different storage conditions for submission of a global dossier.

Q1B                   Stability testing : Photostability testing of new drug substances 
                           and products.
                          The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1996.
                               This forms an annex to the main stability Guideline, and gives guidance on the basic testing
                                protocol required to evaluate the light sensitivity and stability of new drugs and products.

Q1C                   Stability testing for new dosage forms
                           It extends the main stability Guideline for new formulations of already approved medicines
                                and defines the circumstances under which reduced stability data can be accepted.

Q1D                   Bracketing and matrixing designs for stability testing of new drug
                           Substances and products
                           This document describes general principles for reduced stability testing and provides
                                 examples of bracketing and matrixing designs.

Q1E                    Evaluation of stability data

                            This document extends the main Guideline by explaining possible situations where
                                  extrapolation of retest periods/shelf-lives beyond the real-time data may be appropriate.
                                  Furthermore, it provides examples of statistical approaches to stability data analysis.

Q1F                    Stability data package of registration applications in climate zone
                           III and IV
                           The ICH Steering Committee endorsed the withdrawal of the Q1F Guideline at its meeting
                                 in Yokohama, June 2006 and decided to leave definition of storage conditions in Climatic
                                Zones III and IV to the respective regions and WHO.

Q2  Analytical Validation

Q2 (R2) / Q14         Analyitical procedure development and revision of Q2(R1)
                                 Analytical validation

                                 The Q2(R2)/Q14 EWG will develop a new ICH Quality Guideline, ICH Q14, on
                                            Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on
                                            Validation of Analytical Procedures, with a view to potentially combine both
                                           documents into one, for simplification and clarity. 

Q2(R1) Revision

The scope of the revision of ICH Q2(R1) will include validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. The guideline will continue to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B.
These proposed guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing.

Q14 Analytical Procedure Development Guideline

The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

Q2 (R1)                   Validation of analytical procedures : text and methodology

                           This identifies the validation parameters needed for a variety of analytical methods.
                           It also discusses the characteristics that must be considered during the validation of the
                           analytical procedures which are included as part of registration applications.
                          The tripartite harmonised ICH Guideline on Methodology (previously coded Q2B) was
                          finalised under Step 4 in November 1996. It extends the Guideline Q2A to include the  actual experimental data required, along with the statistical interpretation, for the
                          validation of analytical procedures.
                          The Guideline on Methodology has been incorporated into the Guideline on Text in
                          November 2005 and then renamed Q2(R1), without any changes in the contents of the  two Guidelines.

Q3A – Q3D     Impurities

Q3A  (R2)            Impurities in new drug substances
                  The Guideline addresses the chemistry and safety aspects of
                     impurities, including the listing of impurities in specifications and
                    defines the thresholds for reporting, identification and qualification.
                    The revision of the guideline has allowed clarifying some
                    inconsistencies, to revise the decision tree, to harmonize with Q3B and
                    to address some editorial issues.

                    The Attachment 2 of this guideline has been revised under Step 4 
                   without further public consultation on 25 October 2006 (Q3A(R2))


Q3B (R2)             Impurities in new drug products

                              It complements the Guideline on impurities in new drug substances and provides advice in regard to impurities in products containing new, chemically synthesized drug substances. The Guideline specifically deals with those impurities which might arise as degradation products of the drug substance or arising from interactions between drug substance and excipients or components of primary packaging materials. The Guideline sets out a rationale for the reporting, identification and qualification of such impurities based on a scientific appraisal of likely and actual impurities observed, and of the safety implications, following the principles elaborated in the parent Guideline. Threshold values for reporting and control of impurities are proposed, based on the maximum daily dose of the drug substance administered in the product.
The Attachment 2 of this Guideline has been revised under Step 4 without further public consultation on 2 June 2006 (Q3B(R2)).


Q3C (R7)           Impurities : Guidelines for residual solvents
                     This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

Maintenance Process
A Maintenance process has been done to revise Permitted Daily Exposure (PDE), as new toxicological data for solvents become available. 
Limit values for three residual solvents in drug products were revised on basis of the newly recognised toxicity data; lower PDE for N-Methylpyrrolidone being kept in Class 2 (limited by health-basis) and for Tetrahydrofuran and Cumene being placed into Class 2 from Class 3 (no health-based).
Both revisions (PDE for THF and PDE for NMP) reached Step 4 of the process in September 2002. A corrigendum to calculation formula for NMP was subsequently approved on 28 October 2002. As per the new coding rule, they were incorporated into the core Guideline in November 2005.
In February 2009, Table 2, Table 3 and Appendix 1 of the Core Guideline were updated to reflect the revision of the PDEs for N-Methylpyrrolidone and Tetrahydrofuran (Q3C(R4)).
In October 2016, the PDE for Methyl isobutyl ketone (MIBK) was revised, and Triethylamine (TEA) was added as a news solvent. Based on new data, MIBK was moved from Class 3 (solvents with low toxic potential) to Class 2 (solvents to be limited). The new solvent Triethylamine was included in Class 3 (solvents with low toxic potential) (Q3C(R6)).

In October 2018, the MC approved the error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol (Q3C(R7)). Additionally, the MC approved the publication of Support Documents 1, 2 and 3, which include the summaries of the toxicity data from which PDEs were derived.
Q3C (R8)    Impurities : Guidelines for residual solvents

The Q3C(R8) EWG is currently undertaking a maintenance of the Guideline, which will result in the future Q3C(R8) version, to develop PDE levels for three solvents: 2-methyltetrahydrofuran, cyclopentylmethylether and tert-butanol.

Q3D (R1)      Guidelines for elemental impurities

ICH Q3D Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration. In addition, guidance is provided in Q3D on how to develop an acceptable level for EIs for drug products administered by other routes of administration.

In March 2019, the Q3D(R1) Guideline, which was the result of a revision of the PDE level for Cadmium by inhalation in the Q3D Guideline, reached Step 4 of the ICH process.

Q3D (R2)      Revision of Q3D (R1) for cutaneous and transdermal products

ICH Q3D(R1) Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration. In addition, guidance is provided in Q3D(R1) on how to develop an acceptable level for EIs for drug products administered by other routes of administration.

The Q3D(R2) Maintenance EWG is currently undertaking a maintenance of the Guideline to develop PDE levels for cutaneous and transdermal products.

Maintenance Process
A Maintenance Procedure applies to revision of the Q3D(R1) Guideline for Elemental Impurities. These changes includes the incorporation of Permitted Daily Exposure (PDE) for new elemental impurities(EI)/routes of administration and revising the PDE for EI already listed in Q3D(R1) as new toxicological data for EI becomes available.

Products administered on skin and its appendages (e.g., hair, nails) remain the largest area where PDEs for EIs have not been established. In September 2016, the ICH Management Committee approved the revision of the ICH Q3D Concept Paper to include PDEs for the cutaneous and transdermal Route of Administration to continue the process of harmonisation, where necessary. This leads to the establishment of an Expert Working Group (EWG) to develop PDEs levels for all 24 EI included in the Q3D(R1) Guideline for products administered by the cutaneous and transdermal routes of administration.

Q3D training        Implementation of guideline for elemental impurities

This Implementation Working Group (IWG) was endorsed by the ICH Steering Committee in October 2014. Throughout the development of the Q3D Guideline, external audiences, constituents and interested parties have clearly communicated the complexity of the implementation approaches for this guideline. While the Q11 Guideline provides the framework, it cannot provide the detailed examples covering the breadth of potential case studies for products within scope of the guideline. Consequently, the ICH SC considered that the development of a comprehensive training programme and supporting documentation sponsored by ICH was necessary to ensure the proper interpretation and effective utilisation by industry and regulators alike to enable a harmonised and smooth implementation of Q3D on a global basis.

Q4 – Q4B       PHAMEMACOPIEIAS

Q4             Pharmacopoeias

Q6A activity provided the framework on how to set specifications for drug substances to address how regulators and manufacturers might avoid setting or agreeing to conflicting standards for the same product, as part of the registration in different regions.  The resulting ICH Q6A Guideline provides harmonised guidance in this area.  With the passage of the Chemical Substances (Q6A) ICH Guideline, the harmonisation of several compendial test chapters has been considered as critical by the ICH Steering Committee. These chapters are at various stages of harmonisation among the three pharmacopeial organisations (USP, JP & EP). The three organisations conduct their harmonisation efforts through a tripartite pharmacopeial harmonisation program known as the Pharmacopoeial Discussion Group (PDC).

Q4A       Pharacopoeial Harmonisation

The pharmacopoeial authorities, working together through the Pharmacopoeial Discussion Group (PDG), have been closely involved with the work of ICH since the outset and harmonisation between the major pharmacopoeias, which started before ICH, has proceeded in parallel. The ICH Steering Committee receives regular reports on the status of pharmacopoeial harmonisation at its meetings.

Q4B         Evaluation and recommendation of pharmacopoeial texts for use in
                 the ICH region

This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions and since 2010 in Canada. Following favourable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.
Given the nature of this topic, no Concept Paper was developed for Q4B.

Q5A – Q5E        QUALITY OF BIOTECHNOLOGICAL PRODUCTS

Q5A (R1)       Viral safety evaluation of biotechnology products derived from cell
                        Lines of human or animal origin

 This is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. The purpose is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation studies.
(Please note that a typographic error has been corrected on 23 September 1999 on Table A-1. the Genome of the Reovirus 3 is RNA (and not DNA as previously printed). The correction was integrated in the Guideline that was then renamed Q5A(R1)).

Q5B        Analysis of the expression construct in cells used for productions of
                r-DNA derived protein products

 It advises on the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.

Q5C        Stability testing of biotechnological / Biological products

 This document augments the stability Guideline (Q1A above) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or polypeptides.

Q5D        Derivation and characterization of cell substrates used for production
                of biotechnological / biological products

 This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

Q5E        Comparability of biotechnological / biological projects subjects to
                changes in the manufacturing process

 The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Therefore, this guideline is intended to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product. The document does not prescribe any particular analytical, nonclinical or clinical strategy. The main emphasis of the document is on quality aspects.

Q6A – Q6B       SPECIFICATIONS

Q6A          Specifications : test procedure and acceptance criteria for new drugs
                 substances and new drug products : Chemical substances

 This addresses the process of selecting tests and methods and setting specifications for the testing of drug substances and dosage forms. Account has been taken of the considerable guidance and background information which are present in existing regional documents.

Q6B          Specifications : Test procedures and acceptance criteria for
                  biotechnological / Biological products

This document provides guidance on justifying and setting specifications for proteins and polypeptides which are derived from recombinant or non-recombinant cell cultures. The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate. In view of the nature of the products, the topic of specifications include in-process controls, bulk drug, final product and stability specifications and give guidance for a harmonised approach to determining appropriate specifications based on safety, process consistency, purity, analytical methodology, product administration and clinical data considerations.

Q7           GOOD MANUFACTURING PRACTIVE

Q7         Good manufacturing practice guide for active pharmaceutical
               Ingredients

Early in the ICH Process it was agreed that there was adequate international agreement on the technical aspects of Good Manufacturing Practices (GMP) for Pharmaceutical Products and that further harmonisation action through ICH was not needed. Recently, however, attention has focused on the need to formalise GMP requirements for the components of pharmaceutical products - both active and inactive. In February 1998, the ICH Steering Committee agreed that GMP for Active Pharmaceutical Ingredients (APIs) should be adopted as an ICH Topic.
When this topic was adopted, the Steering Committee took steps to ensure that due account was taken of the work already in progress by PIC/S, FDA, United States and other parties. In view of the unusually wide implications of this Topic, a much extended EWG has been established which includes, in addition to the six ICH parties and the Observers, experts representing IGPA (generics industry), WSMI (self medication industry) and PIC/S. With respect to the latter representatives from China, India and Australia have been invited to participate.

Q7  Q&As         Questions and Answer : GMP guide for active pharmaceutical
                            Ingredients
Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.

Q8             PHARMACEUTICAL DEVLOPMENTS

Q8 (R2)           Pharmaceutical developments

This Guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However the principles in this guideline are important to consider during these stages. This guideline might also be appropriate for other types of products. To determine the applicability of this guideline for a particular type of product, applicants should consult with the appropriate regulatory authorities.
The annex to the tripartite harmonised ICH text was finalised under Step 4 in November 2008 and incorporated into the core Guideline, which was then renamed Q8(R1).
The annex provides further clarification of key concepts outlined in the core Guideline. In addition, this annex describes the principles of quality by design (QbD). The annex is not intended to establish new standards: however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Where a company chooses to apply quality by design and quality risk management (Q9: Quality Risk Management), linked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches  (see Q10: Pharmaceutical Quality System).
The Q8(R1) Guideline was revised in Summer 2009 to reflect minor corrections to Example 2 on page 23 (Q8(R2)).

Q8/9/10   Q&As           Q8/Q9/Q10 – Implementation

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the ICH Q8(R2), Q9 and Q10 Guidelines have resulted in the need for some clarification. The Questions and Answers developed by the Quality Implementation Working Group (IWG) are intended to facilitate the implementation of the Q8(R2), Q9 and Q10 Guidelines, by clarifying key issues.
The document with the first and second set of Q&As was finalised under Step 4 in April and June 2009, respectively.
In October 2009, a third set of Q&As was developed and approved by the Steering Committee for integration in the Q&A document (Q8/Q9/Q10 Q&As (R3)).
In November 2010, a fourth set of Q&As was developed and approved by the Steering Committee for integration in the Q&A document (Q8/Q9/Q10 Q&As (R4)).
implementation of Q8(R2), Q9 and Q10, which supplement the existing Questions & Answers and workshop training materials already produced by this group. The document with the first and second set of Points to Consider Document was finalised in June and November 2011, respectively.  

Q9       QUALITY RISK MANAGEMENT

This Guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.

Q10      PHARMACEUTICAL QUALITY SYSTEM
This Guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each Stages.
Q11       DEVLOPMENT AND MANUFACTURING OF DRUG SUBSTANCES
This new guidance is proposed for Active Pharmaceutical Ingredients (APIs) harmonising the scientific and technical principles relating to the description and justification of the development and manufacturing process  of Drug Substances including both chemical entities and biotechnological/biological entities.
QUESTIONS & ANSWERS : Section and justification of starting materials for the manufacturure of drug substances
 Implementation of the ICH Q11 Guideline and its recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials.
The Q11 Implementation Working Group (IWG), established by ICH in 2014, developed a Questions and Answers (Q&A) document which reached Step 2b of the ICH Process in November 2016. These Q&As are intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

Q12       LIFECYCLE MANAGEMENT
Technical and regulatory consideration of pharmaceutical products lifestyle management
This new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more  predictable  and efficient manner across the product lifecycle. Adoption of this new ICH Guideline will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and includes a core Guideline as well as Annexes.
Q13       CONTINEOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS
This new Guideline is proposed to:
• Capture key technical and regulatory considerations that promote harmonisation, including certain Current Good Manufacturing Practices (CGMP) elements specific to Continuous Manufacturing (CM),
• Allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the manufacture – drug substances and drug products – of small molecules and therapeutic proteins for new and existing products,
• Provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of CM technologies used in the manufacture of drug substances and drug products.

Q14      ANALYTICAL PROCEDURE DEVLOPMENT
Work on the development of the Q14 Guideline on Analytical Procedure Development is performed by the Q2(R2)/Q14 EWG.