Documentation is the key to gmp compliance and ensures traceability of all. A static record format, such as a paper or pdf record, is one that. Good manufacturing practices gmp who defines good manufacturing practices gmp as that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization ref 27. Documentation and recordsharmonized gmp requirements journal of y oung pharmacists vol 3 no 2 147 the quality units can delegate to the production unit the. General introduction to gmp, history, ich, pics, eu, fda. Quality management software for life sciences maintain. Developing a pharmaceutical quality system quality management is a wideranging concept.
For technical information, call 2047957968 or 2047958418 in winnipeg. Documentation may exist in a variety of forms, including paperbased, electronic or. A quality manual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities clause 1. Permission is granted to copy, distribute andor modify this document under the terms of the gnu free documentation license, version 1. The basic concepts of quality management, good manufacturing practices and quality risk management are interrelated. Guide to good manufacturing practice of cosmetic products. International gmp requirements for quality control. A new section on quality risk management is introduced as section 2.
Ramniwas directorregulatory and quality affairs pharmaocean,vadodaraindia 1. Good manufacturing practices gmps are also known as prerequisite programs. Document owners are required to ensure that the documentation and re. For developers of gmpbased applications an analysis feature is available. During 2012 the secretariat was made aware that the current good manufacturing practices gmp for pharmaceutical products.
Basicsthe management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and archiving of all gmp documentation and records within that department or unit. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice gmp. These included the concept of risk management, replacing drugs by the term medicines and introducing the concept of a quality unit. Phil management senior chemist, albert david limited. Gmp, and quality risk management ec gmp guide part i chap. The management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and archiving of all gmp documentation and records used within one sites department or unit. All hods shall be responsible to follow this sop for maintaining control on all. Documentation on paper in electronic form photocopy of another document 2 good documentation practices 3. Generate regulatory reports to submit to agencies like the fda or produce during a gmp audit or inspection. The management of each operational site is required to define responsibility for. The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records.
Our management report on electronic document management systems offers a sensible approach for planning and implementing a document management system. All personnel must be aware of and be trained to the quality regulations, procedures, guidelines and company standards applicable to their area of responsibility. Good practices in production and quality control, provides guidance. Good manufacturing practices gmp, but in addition, other gmp regulationsguide.
The documentation and records are a critical element of the food safety management system. All hods shall be responsible to follow this sop for maintaining control on all documents. Documentation database as a confidential document to management of the audited area and manufacturing management team. Introduction because the pharmaceutical industry has traditionally focused upon the application of good manufacturing practice gmp, it has been slow to consider the potential benefits to be gained by implementing an en iso 9001 quality management system qms. Who good manufacturing practices for pharmaceutical. A who guide to good manufacturing practice gmp requirements part 1. Methods of recording of data rectification of written data includes. Proposal and need for new guidance document discussed.
Documentation helps to build up a detailed picture of what a manufacturing. Quality management, premises, equipment, personnel, sanitation, raw material testing, manufacturing. In chapter 1 of eu gmp, covering the pharmaceutical quality system, it states the pharmaceutical quality system should be defined and documented. This 11page standard operating procedure sop describes the procedures for completing all gmp relevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution and archiving. Documentation and recordsharmonized gmp requirements 148 journal of y oung pharmacists vol 3 no 2 record details if you deviate from a procedure. Usp quality systems gmp audited verification program. The basic concepts of quality management, good manufacturing practice gmp and quality risk management are interrelated. Basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. The records will enable you to evaluate the system, show that work was done in a manner that was planned and approved, and show that work and product. Good documentation and quality management principles vimal sachdeva technical officer inspector, who prequalification of medicines programme. A who guide to good manufacturing practice gmp requirements. Introduction and background this guideline highlights, and in some instances clarifies, the application of data management procedures for all gmp documents. Sep 04, 2018 in chapter 1 of eu gmp, covering the pharmaceutical quality system, it states the pharmaceutical quality system should be defined and documented. In most countries compliance with good manufacturing practices gmp 1, 2 including.
Good manufacturing practices guide for drug products. Document management software for gmp compliance gmp. An amendment is made to part ii of the gmp guide to incorporate principles of quality risk management in line with the ich q9 guideline on quality risk management. Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with gmp requirements. To lay down a procedure for control of documents and documented data. This standard operating procedure is applicable for the control of documents and documented data at the formulation plant of pharmaceuticals company name with location. The management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and. The various types of documents and media used should be fully defined in the manufacturers quality management system. They are described here to emphasize their relationships and fundamental importance to the production and control of drugs. Gmp document management, sop standard operation procedure. Requirements for good documentation practice gdp learn all about the good documentation practice including basics, gmp document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of gmp records.
The author is the director of institute of good manufacturing practices india igmpi email. It lays down guidelines for preparation, recording and correction of data and maintenance of records throughout the lifecycle of a document. Various different aspects must be considered in order to transfer documentation management, including knowledge and information management, from a paperbased system into an electronic it system. Documentation system all qualityrelated areas covered.
A revised draft document was subsequently prepared by the authors, the drafting group, based on the feedback received during this consultation and the subsequent who workshop on data management. Amendments correspond to similar changes made to part i chapter 1 of the guide and published in february 2008. Scanned documents, converted to pdf files, are very useful for companies or department. Good manufacturing practice gmp regulations require that all documentation be issued, managed and controlled using a document management system. Create database software based or manual system to assist in. How to implement good documentation practices pharmout. They will help control your processes and ensure that they are done in a consistent and approved manner. Abstract proper documentation and record maintenance is a principal step in good manufacturing practice regulations that a pharmaceutical manufacturer must follow. Gmp term that is recognized worldwide for the control and management of manufacturing and quality. Quality management system subcomponent 3a gmp standardsdetails scope of gmp critical 26 gmps are covered within a regulatory framework. Good manufacturing practices gmp policy manual in order to ensure that products are handled safely and effectively at all times whilst within the company premises a good manufacturing practices gmp policy manual has been developed and implemented. Master gmp documents issued and used by manufacturing functions, departments or sites to verify. A quality manual what is it and what should it contain.
Quality management system integrating gmp into iso 3 b. This 11page standard operating procedure sop describes the procedures for completing all gmprelevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution and archiving. Guide to good manufacturing practice for medicinal products. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. You can nearly guarantee your documentation procedures and data integrity recordkeeping systems validation reports will be targeted in your next gmp eu gmp audit or other quality management system inspections. The management of the signature record should be governed by a. Via gmp any functionality of the vulnerability management can be controlled. An extremely important part of gmp is documentation of every aspect of the process, activities, and operations involved. Why 1 good documentation practices because, if you did not document it, it did not happen. Inadequate compliance with good documentation practices gdocp is a frequent fda and tga audit failure finding. They must receive basic, job specific, continuing and refresher training relevant to their needs and appropriate to their duties.