Apr 25, 2019 life will be so much easier for everyone, including the people you send files to, if you start implementing these 10 best practices. Good documentation practices describe the required activities and steps to use when recording data and other handwritten entries. Good documentation practices gdps in pharmaceutical industry. Pdf the effective control and management of documentation is a critical part of the gmp program within the organization. Organization of the data file s and layout of the variables, where applicable version. Usp chapter good documentation guideline is a general chapter in us pharmacopeia that covers the usp chapter and all aspects of gdp including practices for writing and correcting documentation. Good documentation practice in pharmaceuticals pharmatutor. While some gdp gdocp standards are codified by various competent authorities, others are not but are.
A backup means a copy of one or more electronic files created as an alternative in case the. A good documentation structure provides an assurance of the quality of product. Documentation practices and records control about this document purpose this procedure describes general documentation practices used to complete documents and records and general policies to control those documents and records. Pdf on mar 8, 2017, krishan kumar and others published good documentation practices gdps in pharmaceutical industry find, read and cite all the research you need on researchgate. Good practice definition food and agriculture organization.
Quality risk management to ensure good data management 177 6. All documents must be organized into files which must be stored and maintained for specified periods of time after the expiry date of the product and must be easily retrievable. Ppt good documentation practices powerpoint presentation. All employees of quality assurance, quality control, production, warehouse, engineering. Designing and validating systems to assure data quality and reliability 183 11. Elements of good documentation a tip sheet for documenting.
An easy to understand guide to good documentation practices author. A digest value computed for each file that can be used to detect changes. Unique datetime stamp and identifier for each version checksum. List all the version of the files along with the major edits you did in each version. Abstract the effective control and management of documentation is a critical part of the gmp program.
Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with gmp requirements. Address a need for descriptions of what constitutes good documentation records of all types that are clear, accurate, and complete. How to implement good documentation practices pharmout. Good documentation practice gdp, standard operating procedures sops, pharmaceutical industry i. Sop on good documentation practices pharmaceutical guidance. The principles of good documentation practices are applicable to both paper. Ensuring there is a controlled, documented system to manage gmp related documents and records in compliance with local regulations. Good documentation practice commonly abbreviated gdp, recommended to abbreviate as gdocp to distinguish from good distribution practice also abbreviated gdp is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. Good documentation practices journal of validation technology. Data management best practices evaluation checklist.
The various types of documents and media used should be fully defined in the manufacturers quality management system. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. Performance and monitoring no image available here you can find all existing best practices on application performance. If the optimization fails, you have the option to upload the file.
Ddm8 good documentation ccr clinical research operations. Manager quality assurance slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Documentation practices, continued signatures the governing procedure or the document itself will indicate what the actual signature means. It outlines documentation standards and practices required within the children, youth and family system of care. All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial. Objectives recognize the importance of methodical and organized documentation in research become familiar with record retention requirements. Memo to file may be used as supporting documentation for an approved document. Elements of good documentation a tip sheet for documenting social work service delivery in order to comply with cfsa requirements and best practice standards it is important to document all client contacts, assessments, and the delivery of case management services. The investigatorinstitution should take measures to prevent accidental or premature destruction of these documents. Good documentation practices gdps in pharmaceutical industry author. Security no image available here you can find all existing best practices on application security. Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing. Document all the activities performed do not perform the activity if it is not documented.
The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. 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. Signatures in documents should fall into one of the following categories. Source documentation all study data should be supported by source documentation. Usp chapter good documentation guidelines easy global. Home how to write a good documentation library guides. United states army medical research and materiel command united states army medical research institute of chemical defense good documentation practice office of regulated studies 11 february 2009 usamricd. The documentation should occur at or near the time the services were rendered. Prevent unintended use of obsolete documents, and archiving. Good documentation practice gdp routinely used within the. Do the glps apply to validation trials conducted to confirm the analytical. Best practices for file naming menu how you organize and name your files will have a big impact on your ability to find those files later and to understand what they contain. Life will be so much easier for everyone, including the people you send files to, if you start implementing these 10 best practices. This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of pharmaceutical company name.
As per gmp documentation control if it is not written down, then it did not happen. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. Na can only be used when it is very clear that a portion of a document, form, record does not apply provide an explanation with the na example na. Usp chapter good documentation guidelines easy global training. Good documentation practices free download as powerpoint presentation. Document it and complete the step at that time if possible, noting the actual date it was completed. Foundation of a sound documentationsystem begins with the engineeringdocuments as well as their management. Scribd is the worlds largest social reading and publishing site.
Compliance with the food and drug administrations glp, or good laboratory practices, regulations 21 cfr part 58, as well as gmp regulations for drugs and medical devices 21 cfr part s 211 and 820 requires the use of good documentation practices. Good documentation practices gdps in pharmaceutical. Documentation may exist in a variety of forms, including paperbased, electronic or. Explanatory notes for industry on the preparation of a site master file. Contracted organizations, suppliers and service providers 180 8. Good documentation practices ann glasse, rn, bsn, mba director, regulatory support author. To lay down the procedure for good documentation practices in facility.
Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is. Be consistent and include similar information in all file names of the same file type. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of noncompliance. Good documentation and record management practices in a gmp regulated plant. Guidance documents good manufacturing practices canada. Documentation practices and records control about this. Batch record is an important document kept along with reserve sample until one year of expiry of the product.
The document provides information on when, where, who, why and how to. Due to the importance given to documentation in pharma good documentation practices is required. We recommend you to follow these guidelines for using an optimized pdf file and guarantee a great user experience. These records are made up of government and legally mandated elements, documents required by company policy and practice, documents suggested by best human resources practices, and formal and informal record keeping about employment events. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. Good documentation and record management practices in a. Good documentation practices should beeveryones concern. An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Documentation practices 100608 validation plus, inc. Krishan kumar, laboratory for translational research in imaging pharmaceuticals, wright center of innovation in biomedical imaging, department of radiology, the. The principles of good documentation practices are applicable to both paper and electronic data or.
Clinical data managers under contract to the ccr are not allowed to document in the medical recordcris. Documentation is the written and retained record of employment events. Performed by signature of the person executing a procedure, operation, calculation, etc. You should be consistent and descriptive in naming and organizing files so that it is obvious where to find specific data and what the files contain. Good documentation and record management practices in a gmp. Documentation practices and records control about this document. It will explain the general concept and will provide information as to what needs to be documented in certain records. Validation is the holdup and everyone just wants to pass the baton. The department of medicine clinical research unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the best practices related to documentation.
Gdps are enforced by regulatory agencies such as the fda, tga, emea, health canada or who. Apply coding conventions, such as file organization, comments, naming conventions, programming practices, etc. Breaking the entire process of msb electronic signature workflow into its constituent parts digitizing the whole document life cycle. However, the use optimized file option will be grayed out in the file properties and the original document will be used instead. Best practices for uploading pdfs and resolving common. Do the glps apply to validation trials conducted to. Various documents are producing by pharma company would be discussed below. Apr 17, 2018 apply coding conventions, such as file organization, comments, naming conventions, programming practices, etc. Here you can find all existing best practices on application performance. The content of this presentation is for reference only and should not in anyway be used in place of your company gdp policy.
Correct, complete, current, and consistent information effectively meet customer and stakeholder requirements helps to reduce observations raised on inadequate documentation practices. Home how to write a good documentation library guides at. Aug 23, 2009 good documentation practices presentation 1. Develop a file and folder naming convention and document it so all team members can follow it.
Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study. Krishan kumar, laboratory for translational research in imaging pharmaceuticals, wright center of innovation in biomedical imaging, department of radiology, the ohio state university, columbus, oh 43212, usa. Phil management senior chemist, albert david limited. Good documentation practice is an expected practice.
Oct 31, 2014 medical record documentation is part of good documentation practices. Coordinate regulatory requirements in pharmaceutical manufacturing industry joymalya bhattacharya, m. 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. A good practice is not only a practice that is good, but a practice that has been proven to work well and produce good results, and is therefore recommended as a model. This manual has been developed as a resource for providers of bhrs. Good manufacturing practices guide for drug products gui0001 effective on 20181001 annex 1 to the good manufacturing practices guide manufacture of sterile drugs gui0119 effective on 20181001 risk classification guide for drug good manufacturing practices observations gui0023 20180228 pics annex 1. In this article i am trying to put together some important aspects of good documentation practices and how they could be useful to avoid the form 483 citations and or warning letters. Engineering is the provider production is the customer qa is the gatekeeper. It will explain the general concept and will provide information as to what needs to be documented in. Good clinical practice study documentation medicine. Good documentation practices, commonly referred to as gdps, are the guidelines that one follows in recording raw data entries in a legible, traceable and. An easy to understand guide to good documentation practices. General chapter provides guidelines on how to develop and maintain good documentation practices.