Procedure clinical research documentation involves a variety of documents from various sources and often completed by several people. There are two primary types of documentation used to manage and record gmp compliance. All employees of quality assurance, quality control, production, warehouse, engineering. After reading it, you will be prepared to perform simple tasks using a version control system, and to learn more from other documents that may lack a highlevel coneptual overview. Operator initialling on paperwork fda good documentation practices. Tap 21 also presents the knowledge, skills, and attitudes ksas counselors need. A workshop will be held may 22 and 23 at usp in rockville to discuss comments on good distribution practicessupply chain integrity 1083 that have been received from industry. The documentation should occur at or near the time the services were rendered. Good documentation practice is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and. 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. What is the criteria to cite an good documentation practices observation as an data integrity related issue. Sop on good documentation practices pharmaceutical guidance.
Thank you for your interest in good documentation practices. Sep 14, 2017 live webinar recording on good documentation practices sample diy brick rocket stove cooking without electrical power duration. The lack of such good documentation practices are routinely cited in fda 483 observations. All work should be documented at the time work is performed. Successful technology transfer requires more than presenting good information. So, i will just write the 10 am check in on my documentation now 9.
Good documentation practice gdp, standard operating. Appropriate good documentation practice should be applied with respect to the type of document. What is in the documentation that helps communicate to others. They misinform, they slow down, they incite despair in new community members and laziness in existing ones. In clinical researches, there is a need of good documentation practice when a trial is being carried out. Good documentation practice documentation is a record of our product history. For this reason good documentation practicescommonly referred to as gdpsare critical. International drug and medical device industries standards, referred to. Records should be completed at time of activity or when any action is taken. Correct the errors properly report the deviations if any and implement the capa train all. Performed by signature of the person executing a procedure, operation, calculation, etc. Gdp lays down the guidelines for preparation, recording, and correction of data as well as the maintenance of the records throughout the lifecycle of a document. While some gdp gdocp standards are codified by various competent authorities, others are not but are.
This document is a brief introduction to version control. Live simple, live free tinyhouse prepper recommended. Best practices enable the proper organization, documentation, and preservation of data. Also, find out if your company qualifies for 100% grant funding for this openenrollment or inhouse course.
Adolescent sexual and reproductive health programs in humanitarian settings. Good documentation practices, commonly referred to as gdps, are the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner. Unfortunately, inefficient documentation is among the most regular inspection findings which is a real drawback when it comes to clinical conducts. The six participating companies in the qf nominated one senior manager each to study the best practice and frame the guideline. Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. Home how to write a good documentation library guides at. Keeps a record of all the good work the provider and member are doing together opportunity to show that you have a relationship with the member that is necessary, productive, and measurable no one knows the member like you do no one can read your mind. Guidance for good documentation practice clarifies application of data management procedures throughout the lifecycle of the document includes preparation, recording and correction of data and maintenance of records provides guidance for best practices for both manual and electronic documentation provides guidance on shifting. An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. For newly hired personnel, it was subdivided to two phases of training 1. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. Pdf the effective control and management of documentation is a critical part of the gmp program within the organization.
Good documentation practice is an expected practice. Documentation practices and records control about this. Fund unfpa and brad kerner of sc were catalytic in prioritizing documentation of good practices in this field and provided technical guidance for this report. The publication was originally conceived and written by the national addiction technology transfer center attc. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. The document provides information on when, where, who, why and how to. Documentation is often used as evidence during litigation. Correct, complete, current, and consistent information effectively meet customer and stakeholder requirements helps to reduce observations raised on inadequate documentation practices.
As per gmp documentation control if it is not written down, then it did not happen. Who gmp, volume 2 good documentation practice is an expected practice. This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of pharmaceutical company name. Records and reports related to production events represent the only official, documented record of. List all the version of the files along with the major edits you did in each version. Dear all, i would like to ask opinions and suggestions based on our existing training sop for improvement. Suitable controls should be implemented to ensure the accuracy, integrity, availability and. Introduction and background this guideline highlights, and in some instances clarifies, the application of data management procedures for all gmp documents. It lays down guidelines for preparation, recording and correction of data and maintenance of records throughout the lifecycle of a document. Correct, complete, current, and consistent information effectively meet customer and stakeholder requirements helps to reduce observations raised on inadequate. Documentation that is used in support of manufacturing. A number of people deserve recognition for their tireless and dedicated work on this document. Good recordkeeping not only helps you during regulatory inspections gmp audits, it is mandatory to ensure your documentation practices and your products meet industry standards and legal requirements for safety, efficacy and product quality. If your documentation is nonexistent or incomplete, there is no evidence to support your recall of events, and an attorney can call it into question.
Change your documentation in the same cl as the code change. Elements of good documentation a tip sheet for documenting. Phil management senior chemist, albert david limited. Adolescent sexual and reproductive health programs in. The gdp can be defined as good documentation practice is an essential part of the quality assurance and such, related to all aspects of gmp this definition is based on who. Apply coding conventions, such as file organization, comments, naming conventions, programming practices, etc. Good documentation practices gdocp are key components of gmp compliance. Training checklist good documentation practice gdocp. Good documentation practices gdp documentation is one of the most valuable assets in the regulated healthcare industry. Documents must be clearly and legibly written or created.
Data management best practices evaluation checklist. Documentation practices 100608 validation plus, inc. Good documentation practices for linked paper and electronic records. Contact us for more information and training dates regarding this course and a qsg representative will call you as soon as possible. Good documentation practice gdp or gdocp, a term used in the pharmaceutical industry, is essential for the integrity of data collection and reporting for supporting development. Good clinical practice as defined by ich e6 is a standard for the design, conduct, perf. They misinform, they slow down, they incite despair in new.
Clearly written documents prevent errors of various activities in pharma each and every activity is written in specific documents such as sops and strictly followed. Gdp good documentation practices quality support group. Guidance on good data and record management practices. An easy to understand guide good documentation practice the moaning was replaced with buzzing as a new project was born. 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. Though documentation on construction projects costs money to prepare and maintain, construction documentation has become as essential to completion of a successful construction project as the plans and specifications pursuant to which the job is built. Mar 03, 2018 version control concepts and best practices by michael ernst september, 2012 last updated. 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.
How to implement good documentation practices pharmout. Informational bsi mdr documentation submissions best practices guidelines. Ich e6 good clinical practice gcp guidance, sections 4. Scope this sop applies to all studies where the ectu clinical team will be responsible for collecting and recording study data. An easy to understand guide good documentation practices gdp.
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. Bad documentation practice signing for work prior to that work being performed example. Good documentation practice gdp routinely used within the pharmaceutical. Information generated during the many years of healthcare product development must be properly documented so that correct, complete and consistent information can be provided to your. The reasons for such setbacks are many and can be varied. Attend this webinar to learn proper methods for documenting data in the highly regulated pharmaceutical industries. Attend this webinar to learn proper methods for documenting data in. I am going on break at 10 am and have an observation check due. Jul 02, 2009 bad documentation practice signing for work prior to that work being performed example. Coordinate regulatory requirements in pharmaceutical manufacturing industry joymalya bhattacharya, m. Anil arora cadila healthcare, sanjeev asgekar cipla, sanjay s shetgar dr reddys. Documentation practices, continued signatures the governing procedure or the document itself will indicate what the actual signature means.
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. Pdf good documentation practices gdps in pharmaceutical. An essential part of the quality assurance system and should exist for all aspects of gmp reference. To lay down the procedure for good documentation practices in facility. Feb 24, 2018 good documentation practice documentation is a record of our product history. Home how to write a good documentation library guides.
Apr 17, 2018 apply coding conventions, such as file organization, comments, naming conventions, programming practices, etc. Signatures in documents should fall into one of the following categories. Gdps apply to everyone who documents activities related to cgmp or current good. Selected fda gcpclinical trial guidance documents fda. It recommends that the records should be made or completed at each time any action is taken. The use of gdp allows companies to comply with regulatory requirements such as good laboratory practices glp, good manufacturing practices gmp or the applicable quality management system for example, iso 485, 21 cfr 820, or good clinical practices gcp in canada, the us and the eu. If your documentation is solid, it can help support your oral account of events and demonstrate that you met or exceeded the standard of. Live webinar recording on good documentation practices sample diy brick rocket stove cooking without electrical power duration.
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