GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

This document was written with the aim of:

Providing guidance for inspectorates in the interpretation of GMP/GDP requirements in relation to data integrity and the conduct of inspections.

Providing consolidated, illustrative guidance on risk-based control strategies which enable the existing requirements for data integrity and reliability as described in PIC/S Guides for GMP2 and GDP3 to be implemented in the context of modern industry practices and globalised supply chains.

Facilitating the effective implementation of data integrity elements into the routine planning and conduct of GMP/GDP inspections; to provide a tool to harmonise GMP/GDP inspections and to ensure the quality of inspections with regards to data integrity expectations.

This guidance, together with inspectorate resources such as aide memoire (for future development) should enable the inspector to make an optimal use of the inspection time and an optimal evaluation of data integrity elements during an inspection.

Guidance herein should assist the inspectorate in planning a risk-based inspection relating to data integrity.

This guide is not intended to impose additional regulatory burden upon regulated entities, rather it is intended to provide guidance on the interpretation of existing PIC/S GMP/GDP requirements relating to current industry practice.

 The principles of data integrity apply equally to both manual and computerized systems and should not place any restraint upon the development or adoption of new concepts or technologies. In accordance with ICH Q10 principles, this guide should facilitate the adoption of innovative technologies through continual improvement. 3.6 This version of the guidance is intended to provide a basic overview of key principles regarding data management and integrity. The PIC/S Data Integrity Working Group will periodically update, amend and review this guidance in light of inspectorate feedback, experience in using the guide and any other developments

  

DATA GOVERNANCE SYSTEM

 What is data governance?

Data governance is the sum total of arrangements which provide assurance of data integrity. These arrangements ensure that data, irrespective of the process, format or technology in which it is generated, recorded, processed, retained, retrieved and used will ensure a complete, consistent and accurate record throughout the data lifecycle.

The data lifecycle refers to how data is generated, processed, reported, checked, used for decision-making, stored and finally discarded at the end of the retention period. Data relating to a product or process may cross various boundaries within the lifecycle. This may include data transfer between manual and IT systems, or between different organizational boundaries; both internal (e.g. between production, QC and QA) and external (e.g. between service providers or contract givers and acceptors).

Data governance systems

Data governance systems should be integral to the pharmaceutical quality system described in PIC/S GMP/GDP. It should address data ownership throughout the lifecycle, and consider the design, operation and monitoring of processes / systems in order to comply with the principles of data integrity, including control over intentional and unintentional changes to, and deletion of information.

The data governance system should ensure controls over data lifecycle which are commensurate with the principles of quality risk management. These controls may be:

· Organizational

o procedures, e.g. instructions for completion of records and retention of completed paper records;

o training of staff and documented authorization for data generation and approval;

o data governance system design, considering how data is generated recorded, processed retained and used, and risks or vulnerabilities are controlled effectively;

o routine data verification;

o periodic surveillance, e.g. self-inspection processes seek to verify the effectiveness of the data governance policy.

· Technical

o computerized system control,

o automation

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Revision of PIC/S GMP Guide PE 009-13 GUIDE TO GOOD MANUFACTURING PRACTICE

Geneva, 22 December 2016: the following Chapters of the PIC/S GMP Guide have been revised:

• Chapter 1 on “Quality Management” (which has become “Pharmaceutical Quality Systems”); 
• Chapter 2 on “Personnel”;
• Chapter 6 on “Quality Control”; 
• Chapter 7 on “Contract Manufacture and Analysis” (which has become “Outsources Activities”).

The revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. Chapters 1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated. A section on consultants has been added in Chapter 2. The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”. Both Chapters 1 and 7 have been renamed to reflect the changes. In Chapter 6, all sections have been reviewed and amended and a new section on “Technical transfer of testing methods” has been added.

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP Guide (PE 009-13) will enter into force on 1st January 2017. All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

1.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

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2.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

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3.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS       

   ANNEXES

1.    Annex 1 (Manufacture of sterile medicinal products)

2.    Annex 2 (Manufacture of biological medicinal substances and products for human use)

3.    Annex 3 (Manufacture of radiopharmaceuticals)

4.    Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)

5.    Annex 5 (Manufacture of immunological veterinary medical products)

6.    Annex 6 (Manufacture of medicinal gases)

7.    Annex 7 (Manufacture of herbal medicinal products)

8.    Annex 8 (Sampling of starting and packaging materials)

9.    Annex 9 (Manufacture of liquids, creams and ointments)

10. Annex 10 (Manufacture of pressurised metered dose aerosol preparations for inhalation)

11. Annex 11 (Computerised systems)

12. Annex 12 (Use of ionising radiation in the manufacture of medicinal products)

13. Annex 13 (Manufacture of investigational medicinal products)

14. Annex 14 (Manufacture of medicinal products derived from human blood or plasma)

15. Annex 15 (Qualification and validation)

16. Annex 16 [Qualified person and batch release]*

17. Annex 17 (Parametric release)

18. Annex 18 [GMP Guide for active pharmaceutical ingredients]**

19. Annex 19 (Reference and retention samples)

20. Annex 20 (Quality risk management)***

·         Appendix I: Risk Management Methods and Tools Basic Risk Management Facilitation Methods

·         Appendix II: Potential Applications For Quality Risk Management

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Download Zip: GMP Guide (PE 009-13).zip

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FDA GUIDE 21 CFR 820.20 Management responsibility

Sec. 820.20 Management responsibility

(a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.

(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

(2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.

(3) Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and

(ii) Reporting on the performance of the quality system to management with executive responsibility for review.

(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

Source: FDA (FDA GUIDE 21 CFR 820.20 Management responsibility)

Click here for 21 CFR PART 820.3 Quality System Definitions

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21 CFR PART 820.3 Quality System Definitions

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
SUBCHAPTER H--MEDICAL DEVICES

Sec. 820.3 Definitions

(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to the regulations in this part.

(b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

(c) Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

(d) Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.

(e) Design history file (DHF ) means a compilation of records which describes the design history of a finished device.

(f) Design input means the physical and performance requirements of a device that are used as a basis for device design.

(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.

(h) Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

(i) Device history record (DHR ) means a compilation of records containing the production history of a finished device.

(j) Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.

(k) Establish means define, document (in writing or electronically), and implement.

(l) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

(m) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

(p) Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.

(q) Nonconformity means the nonfulfillment of a specified requirement.

(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.

(s) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

(t) Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.

(u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

(v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

(w) Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

(x) Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

(y) Specification means any requirement with which a product, process, service, or other activity must conform.

(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

(1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

(2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

(bb) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a devicemeans an HCT/P as defined in 1271.3(d) of this chapter that does not meet the criteria in 1271.10(a) and that is also regulated as a device.

(cc) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. A unique device identifier is composed of:

(1) A device identifier --a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and

(2) A production identifier --a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

(i) The lot or batch within which a device was manufactured;

(ii) The serial number of a specific device;

(iii) The expiration date of a specific device;

(iv) The date a specific device was manufactured.

(v) For an HCT/P regulated as a device, the distinct identification code required by 1271.290(c) of this chapter.

(dd) Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States.

Source: FDA

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