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GMP in Practice: 24 chapters written by internationally renowned industry experts.


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Updates Forecast & History


GMP MANUAL Update No. 18

What is new?

GMP in Practice

New Chapters:

  • Chapter 2 Personnel
    • Chapter 2.A Human Resource Management
    • Chapter 2.B Health Monitoring and Occupational Health and Safety
  • Chapter 19. Quality Unit
    • Chapter 19.A Quality Assurance Duties
  • Chapter 10 Quality Risk Management (formerly Considerations on Risk Management, completely new version)

Updated Chapters:

  • Chapter 2 Personnel
    • Chapter 2.C Training

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4.3.1 EU-GMP Guide Part I, Draft Chapter 3 Premises and Equipment
    • C.4.5.1 EU-GMP Guide Part I, Draft Chapter 5 Production
    • C.4.8.1 EU-GMP Guide Part I, Draft Chapter 8 Complaints, Quality Defects and Product Recalls
    • C.6.15.1 EU-GMP Guide Part I, Draft Annex 15 Qualification and Validation
    • C.6.16.1 EU-GMP Guide Part I, Draft Annex 16 Certification by a Qualified Person and Batch Release
    • C.14.1 Good Distribution Practice for Medicinal Products for Human Use Questions and Answers
    • C.17 Guideline on Process Validation for Finished Products – Information and Data to be Provided in Regulatory Submissions
  • Chapter D CFR and FDA Guidelines
    • D.6 Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach
    • D.7 General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Updated Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4.6 EU GMP Guide Part I, Chapter 6 Quality Control

GMP in Practice

Chapter 2 Personnel

2.A Human Resource Management

Modern human resource management does not see employees solely as a production and cost factor, but as part of the intangible assets of the business. The qualification and motivation of the employees contributes greatly to the success of a company.The task of human resource management is to plan the deployment of personnel in such a way that employees with the right qualification are in the right place at the right time. The tasks of human resource management as a result include personnel planning, personnel development, personnel administration and support. Senior management is responsible for quality objectives and their fulfilment. They conduct regular management reviews to ensure that the processes in place are effective. Organisational structures describe the hierarchical structure of a company. The static organisational structure and the dynamic operational structure must both be described.Requirement profiles define qualification attributes that must be present at a workplace to ensure that the post holder can make appropriate decisions and carry out their duties. Job descriptions define the tasks, competences and responsibilities of an employee. A current and approved version of the job description must be available in written form.
(Dr. Michael Hiob)

2.B Health Monitoring and Occupational Health and Safety

Health monitoring of personnel is used to maintain the health of personnel (protection of personnel), and to prevent the spread of pathogens during the manufacture of medicinal products (protection of the medicinal product). For this purpose, initial and follow-up medical examinations are carried out. Occupational health examinations have to be carried out in accordance with occupational insurance association principles based on risk assessments. A distinction is made here between mandatory and voluntary examinations. The company has to ensure health and safety in the workplace in close cooperation with a company doctor. The occupational safety experts support the employer in all questions relating to occupational health and safety and accident prevention.
(Dr. Michael Hiob)

2.C Training

The employees of a pharmaceutical company must have the knowledge and skills required for carrying out their tasks and should only be assigned tasks that they are qualified to do. Regular training of employees is an important requirement which ensures that the employees can carry out their tasks in accordance with GMP. The learning objectives are determined by comparing the requirements profile and the qualification of the employee. When planning training, the content-related and organisational aspects must be taken into account. The trainer must not only have the required specialist knowledge, but also didactic skills, social skills and knowledge of the company. Choosing a suitable training method is an important prerequisite for the success of the training event. The training should be practice-oriented, varied, and take the requirements of the target group into account. Electronic training methods such as e-learning, web-based training and blended learning may be used. Success and/or effectiveness monitoring must be used to check if training is successful. The consent of the works council must be obtained if monitoring is to take place. The training system itself must also be reviewed in order to check its effectiveness. All training activities must be documented to ensure traceability.
(Dr. Michael Hiob)

Chapter 10 Quality Risk Management

10.A Principles and requirements

This chapter describes the basic principles and requirements for the implementation of quality risk management in a company. The relationship between the maturity level of an organisation and the mode of application of QRM is demonstrated. The relationship between the adequate level of QRM effort, rigour and formality required in a particular situation is discussed.
(Martin Mayer)

10.B Potential applications and uses of QRM

Quality risk management can be applied both proactively and reactively. The potential application during the different phases of the product life cycle is described. Quality risk management is part of many of the processes in a pharmaceutical quality management system and must therefore be integrated in these processes. A company greatly benefits from this integration.
(Martin Mayer)

10.C The QRM process

The author describes how a QRM process can be efficiently structured and outlines the individual steps that should be carried out in an ideal situation. The considerations that have to be made during the individual process steps are explained. It is outlined when and how a QRM process should be initiated and what needs to be observed during risk identification, analysis and evaluation. The terms risk control, risk reduction and risk acceptance are also explained. The insights that can be gained from a QRM process are shown, including when and to whom they should be communicated. Another important part of every QRM process is the continuous monitoring of risks that have already been identified.
(Martin Mayer)

10.D Methods and tools of QRM

This chapter provides detailed information on accepted quality risk management methods and tools as well as their application, advantages and disadvantages. The different methods and tools can be - and in many cases should or must be - combined. The QRM methods can and should also be applied stepwise. When QRM methods are applied, supporting statistical methods are often required to analyse data. The basic features of the most important methods are explained.
(Martin Mayer)

Chapter 19 Quality Unit

19.A Quality Assurance Duties

The responsibility for establishing and equipping a working pharmaceutical quality system lies with the pharmaceutical entrepreneur. Regulatory requirements for a pharmaceutical quality system are found in the EU GMP Guide, Part I, Chapter 1, in the ICH guideline Q10 and in the FDA guideline on quality systems. There is no obligation to divide the duties of a quality function into two independent departments of “Quality Control” and “Quality Assurance”. Depending on the size and structure of a company, however, this may be advisable. If such a division is made, the responsibilities of the Head of Production, Head of Quality Control and Head of Quality Assurance must be unequivocally defined and differentiated. Whether or not the quality assurance would then be implemented as an operational line function or a staff function lies within the discretion of the pharmaceutical entrepreneur. Three approaches on how to set up a Quality Assurance function with different tasks and focal points are introduced and discussed. After all, no supervisory function of Quality Assurance over other Quality departments can be derived from any of the European or American regulatory works.
(Dr. Bernd Renger)

GMP Regulations (File A–D)

Chapter C: EU Directives and Guidelines

C.4 EU GMP Guide Part I-Basic Requirements for Medicinal Products

The European GMP Guide is updated continuously to keep it abreast of current demands in a global environment. Chapters 3, 5 and 8 are at draft stage, as well as the Annexes 15 and 16. To make the revision processes more transparent, we decided to include the draft versions into our GMP MANUAL. Where possible, we provide a comparison of the currently valid version with the proposed draft version. The following drafts are included in this update:

  • C.4.3.1Draft Chapter 3 Premises and Equipment
  • C.4.5.1 Draft Chapter 5 Production
  • C.4.8.1 Draft Chapter 8 Complaints, Quality Defects and Product Recalls
  • C.6.15.1 Draft Annex 15 Qualification and Validation
  • C.6.16.1 Draft Annex 16 Certification by a Qualified Person and Batch Release
C.4.6 Chapter 6 Quality Control

The European Commission has published the final version of Chapter 6 Quality Control on April 3, 2014. The revised document will enter into force on October 1, 2014 and then supersede the previous version of 2005. The main changes relate to the inclusion of a new section on technical transfer of testing methods and other items such as the integration of out of specification (OOS) results and trend analysis. The changes compared to the previous version are printed in italic letters.

C.14.1 Good Distribution Practice for Medicinal Products for Human Use – Questions and Answers

On 1 April 2014, the European Commission has published a “Question and Answer” document responding to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use. The 5-pages document lists 25 questions and their corresponding answers.

C.17 Guideline on Process Validation for Finished Products – Information and Data to be Provided in Regulatory Submissions

The EMA has published the final version of the long awaited Guideline on Process Validation on February 24, 2014. It will enter into force in August 2014. The document integrates the modern approach of the ICH Q8, Q9 and Q10 Guidelines, as well as elements of the recently published draft version of Annex 15. The possibility of using continuous process verification in addition to, or instead of, traditional process verification described in the previous guideline has been incorporated in the new guideline. It is pointed out that process validation should not be viewed as a one-off event. A lifecycle approach should be applied linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.

Chapter D: USA: CFR and FDA Guidelines

D.6 Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach

This document explains the FDA's CGMP for the 21st century Initiative as well as the individual charges and achievements of the various working groups that have been involved in the initiative. The report also outlines the path forward in implementing the pharmaceutical quality regulatory system and discusses in some detail various other documents that have resulted from work group activities.

D.7 General Principles of Software Validation; Final Guidance for Industry and FDA Staff

The guidance outlines general validation principles the FDA considers to be applicable to the validation of medical device software or the validation of software used to design, develop or manufacture medical devices. It describes how certain provisions of the medical device quality system regulation apply to software and the agency's approach to evaluating a software validation system.


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