Good Documentation Practices (GDocP) | GMP Basics (2023)

Good Documentation Practices (GDocP) | GMP Basics

GMP Basics of Good Documentation Practices (GDocP)

Good documentation practice (GDocP) is a crucial component of GMP compliance.

More frequently referred to as Good Recordkeeping Practice, good documentation practices are not only helpful during a regulatory inspection (GMP audit), non-conformance/deviation investigation, or product recall. These practices are mandatory to ensure that your documentation — and your products — meet industry standards and other legal responsibilities in the pharmaceutical sector.

Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).

Good documentation practice is good business practice no matter what your organisation services, produces, or sells.

  • Recordkeeping procedures (SOPs) help manufacturing organisations meet their PIC/S GMP requirements (quality standards/risk management standards) and ISO certification expectations.
  • Reliable, accurate, consistently recorded information helps ensure product safety, quality and efficacy.
  • While recordkeeping procedures are an important part of ANY business — they are particularly crucial in pharmaceutical, veterinary medicine and medical device manufacturing industries in view of the potential risks to end-users of their products (i.e. consumers/patients, pets, or livestock).

Good documentation practices are also essential for attaining and sustaining ISO-9001-2015 certification — or other ISO certification specific to your industry, such as ISO/IEC 17025 (for laboratory testing and calibration standards);ISO/IEC 27001 (for information security management system / ISMS), or ISO 13485:2016 (for medical device manufacturing).

FDA Audits and TGA Audits – Recordkeeping/Documentation Citations

You can nearly guarantee your documentation procedures, recordkeeping systems, and data integrity compliance measureswill be targeted in your next GMP/EU cGMP audit or other PQS inspection.

Breaches of GMP regulations in relation to documentation practices/data systems are frequently cited in FDA audits, TGA audits, and inspections by other Regulatory Authorities. To avoid audit findings — and reduce your chances of releasing a substandard product batch into the pharmaceutical supply chain (necessitating a recall) — good recordkeeping is essential.

Good recordkeeping, the foundation of data integrity, requires managerial-level prioritisation of data governance measures.

Your entire organisation must stay up to date with good documentation practices training requirements and QMS/compliance monitoring.

This applies not only to your employees but to your contractors, suppliers/vendors, and distribution personnel (e.g. warehouse workers, product transport companies, and other individuals and businesses involved in manufacturing, packaging, storage, transportation, logistics, and delivery). Good recordkeeping is also mandatory for complaints handling systems, CAPA systems, and post-marketing surveillance activities (pharmacovigilance/adverse event reporting).

Inadequate documentation practices and recordkeeping weaknesses are key targets for FDA inspections, TGA inspections and QMS audits.

Good Documentation Practices (GDocP) | GMP Basics (1)

GDocP vs GDP (Good Documentation Practice vs Good Distribution Practice)

Before we discuss the basics of good documentation practices for beginners, good documentation practices should not be confused with good distribution practices (for which the acronym is GDP).

(Video) Best Video on Good Documentation Practices - Documents and Records | GxP | GMP, Part 1/4

  • Documentation practices should always be referred to as GDocP — not GDP
  • However, some industry publishers still use the same acronym (GDP) for documentation practices as well as for distribution practices (an error).

Double meanings for the acronym GDP could impact your quality management systems and guidelines. Be sure to specify GDocP for good documentation practices or refer to Good Recordkeeping Practice (GRK) as per PIC/S Guidelines.

For Beginners | GMP Basics for Good Documentation Practices

Good Documentation Practices (GDocP) | GMP Basics (2)

GMP expectations, as well as ISO certification, depends upon organisation-wide good documentation practices/good recordkeeping practices.

These expectations including a high-level commitment to data governance, such as maintaining data integrity and computer system/data system validation activities, timely data monitoring, and continuous improvement initiatives.

Aim and purpose of good documentation practices (GDocP) in pharmaceutical and medical device manufacturing

Online GMP courses are typically available immediately upon completion of the online order. These courses will help you (and/or your new employees or contractors) better understand GMP compliance guidelines and industry expectations.

Requirements for GDocP/GRK compliance

In brief, Good Documentation Practice (GDocP) guidelines from organisations such as PIC/S helps to ensure globally-expected standards are met during ALL stages of manufacture and distribution of medicinal products (pharmaceuticals, medical devices, veterinary medicines, etc).

GMP, PIC/S and ISO9001-2015 documentation standards relate to:

  • data accuracy
    • recorded accurately
    • cross-checked for errors
    • not intentionally misleading (prevents fraudulent entries, editable entries)
  • data integrity/validation
    • genuine, true data
    • validated and supported/witnessed; vs intentionally falsified
    • relevant to the reporting requirement
    • not changeable after original recordkeeping entry (extensively tracked changes)
  • reporting/recordkeeping timeliness
    • information is recorded contemporaneously
    • real-time record keeping including date stamps (e.g., automated time-stamping)
    • prevents errors from human memory-reliance issues and prevents editing of original data
  • legibility
    • clarity
    • legible (readable by anyone, removing guesswork)
    • readily accessible
  • identifiable
    • clear records that can identify the person who actually records the data
      • Blockchain is increasingly being discussed as part of Pharma 4.0 innovations
      • watch for other new technology adaptations for GDocP as systems evolve
    • Especially given growing global concerns about counterfeit pharmaceuticals and cosmetic medicines and substandard medicines and fake antibiotics entering global pharmaceutical chains
    • GMP and GDocP requires no shared passwords (and high-tech digital security for data integrity purposes and data entry tracking/logging identification)

Documentation/manufacturing records must meet ALCOA+ standards.

Tips for beginners: additional information on the basics of Good Documentation Practice (GDocP)/GRK.

All personnel, including contractors, are responsible for following regulatory guidelines.

  • Expectations for GDocP/GRK compliance go well beyond being an organisation-wide requirement.
  • These expectations also apply to contractors, service vendors/maintenance workers, equipment installation engineers, raw material suppliers, and any other individuals or companies involved in your manufacturing, production, labelling/packaging operations (and supply chains).

It’s important to be aware of the compliance gaps that lead to GMP audit citations and/or audit failures (audit findings/citations/production line shutdowns and/or facility closures).

Good Documentation Practices (GDocP) | GMP Basics (3)

Documentation AND distribution practices are two key areas where companies often end up inadvertently breaching GMP requirements/PIC/S guidelines for documentation practices.

(Video) What Are Good Documentation Practices (GDocP)? And Great Documentation Tips

As the manufacturer (product sponsor), your organisation is ultimately responsible for ensuring EVERY person involved in the production and distribution of your products has attained appropriate GDocP compliance training (with proof, e.g. assessments/training certificates).

GDocP Investigations, Self-Inspection Findings and GMP Audits

Averting GMP audit findings (GMP compliance breaches, e.g. to avert failing an ISO certification audit, or being subjected to a TGA warning letter/citation or an FDA warning letter/audit citation/fine):

  • GDocP compliance investigations need to be performed regularly.
  • Management must provide/ensure adequate training and monitoring of documentation practices and quality systems, including those used by contractors, key suppliers, and transportation personnel.

Self-Inspections for GDocP compliance are recommended to be performed more frequently than your annual self-inspection requirement.

  • Many manufacturing businesses perform self-inspections more frequently than their annual requirement.
  • More frequent self-inspections (internal audits) can help improve compliance, reduce product risks, and provide ideas for continuous improvements — as well as ensuring the effectiveness of the Pharmaceutical Quality System (PQS).

Good Documentation Practices (GDocP) | GMP Basics (4)“Self-inspections” in the pharmaceutical industry are internal GMP compliance investigations. Internal audits can help reduce product safety and supply chain risks, such as product interception (theft/diversion) and/or product tampering.

And good recordkeeping, along with internal audits, ensures crucial evidence if available for quality assurance, batch release, and batch traceability (a necessity for a product recall).

GDocP/GRK training, and recordkeeping compliance monitoring, in conjunction with other data governance measures, can help reduce your risks of ‘failing’ a GMP compliance audit.

Just remember that good recordkeeping requirements apply to everyone in your distribution supply chain, not just manufacturing-site personnel.

It is applicable to your casual workers/contractors, contract service providers, source material/API suppliers, warehouse workers, and transport/delivery organisations.

All people who have contact with your product, at any stage of production or delivery:

  • require documented, ongoing training in GDocP/GRK compliance
  • are expected to be monitored for GMP/GxP compliance
  • should understand how to identify potential issues with records/data integrity

The FDA and TGA will likely investigate your employee records, and the documentation practices of your suppliers and service providers — including contractors — and they’ll do so in-depth!

That’s because good documentation practices are part of the 10 golden rules of GMP.

(Video) Good Documentation Practices - General Rules

Applicability of GDocP/GRK

  • Good documentation practices (requirements) apply to nearly all delivery regions and countries.
  • While PIC/S guidelines aim to ensure global consistency in terms of manufacturing standards, some regions may have slightly different documentation requirements — DO check before you ship.

Digital recordkeeping systems

If you’re relying on any type of digital recordkeeping system, you must ensure your computerised systems and data collection/data analysis processes are validated according to GMP guidelines/regulatory expectations.

Ensure you comply with data integrity requirements.

Documentation Types | Good Documentation Practices

What types of documents or recordkeeping is required in the pharmaceutical industry or in the production of medicinal cannabis, medical devices, blood and tissue products and veterinary medicine production?

Examples of records for which employees/contractors and suppliers must adhere to good documentation practices (GDocP as part of GMP including GDP or distribution) include, but are not limited to:

  • Analytical Methods
  • Annual Self-Inspection (Procedures, Implementation and Findings/Actions)
  • Batch Records / Supply Sources
  • Bills of Materials (BOMs)
  • CAPA (Corrective Actions and Preventative Actions)
  • Clinical Study Records
  • Cold Chain reports and climate testing measurements/records
  • Complaints and complaint handling/monitoring
  • Continuous Improvements
  • Certificate of Analyses (CoA)
  • Certificate of Compliance (CoC)
  • Deviations
  • Distribution records including Routes, Storage and Delivery Records
  • Incident Reports
  • Laboratory Notebooks / Logbooks
  • Labels (Product Labels and sampling labels)
  • Non-conformances
  • Policies (documentation including approvals and distribution/employee training records)
  • Protocols and changes to protocols (change management system documentation including approvals)
  • Quality management records / QMS systems
  • Recalls and Recall Policies
  • Releases (QMS approvals by trained, competent and authorised personnel)
  • SAE reporting (serious adverse events reporting)
  • Source suppliers and source supply testing/monitoring
  • Standard Operating Procedures
  • Test Methods / Quality Testing methods including validation and recordkeeping
  • Training | GMP training for Employees, Contractors, Suppliers/Vendors including your distribution/warehouse and transportation personnel or contractor(s)
  • Work Instructions (Workflow, procedures, SOPs)
  • Workplace Safety reports/record keeping
  • Validation (methods, reports and related documentation including IQs, OQs and PQs)

Recordkeeping Categories

Documents and records can fall into various classification systems, and in general, there are 4 key classifications for documentation.

  • Primary Records (examples: production formulas, supply source documents, contracts, packaging instructions)
  • Procedures or supporting procedures (instructions and guidebooks, SOPs)
  • Subsidiary records (help meet GMP, e.g. calibration readings reports, print outs, other supporting documents)
  • Quality Control records (testing results, testing methods, recall procedures, investigations, self-inspection reports, CAPA, more)

GDocP | What are the specific requirements for good documentation practices in pharmaceutical production including medicinal cannabis and other herbal medicines, veterinary medicines and medical device manufacturing?

Check your organisations SOPs (Standard Operating Procedures) and work instructions for details.

Basic requirements for good documentation practices will include, but not be limited to, the following components:

  • Accuracy
  • Data Integrity (protected, secure and backed-up data systems)
  • Contemporaneous recordkeeping (timely, immediately/real-time)
  • Legible
  • Readily identifiable as to who recorded it (no shared passwords or shared data system log-ins, no forging of signatures even if requested)
  • Readily accessible when required
  • Signature record log and register
    • initials and signatures of all employees, contractors and suppliers who fill in documentation
    • a secure database to match initials and signatures with the actual identity of the person who recorded the data
  • Security / Data Integrity
    • Data must not be able to be altered or erased once entered or recorded
    • No white-out is permitted in GMP facilities and no gel pens (specific writing instruments are designated in your SOPs and working instructions)
    • Specific rules must be followed when altering a record, such as a legible cross through of the data and the correction listed with your registered initials and the time/date (and reason for the change, depending on the recordkeeping requirements)

For GMP consultancy or GMP audit assistance, including quality management systems and data integrity consultancy, contact PharmOut’s leading consultants (international expertise in GMP industries and PICS compliance including QMS and audit failure recovery.

We have online training for GDocP as well as custom onsite courses and upcoming GMP course training dates.

References, Sources and Further Reading

The Food and Drug Administration (FDA or Agency) – December 2018 (‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers’’ PDF)

Download the FDA guidance paper (December 2018) on Data Integrity and Compliance with cGMP)

(Video) Good Documentation Practices - How to Make Corrections

Other Training Bundles

Or for individual or onsite training courses, review GMP training courses by PharmOut’s GMP Training, learning and development expert, Maria Mylonas and other GMP manufacturing and medicinal cannabis TGA industry experts.

References:

Warehouse, Distribution and GMP Training for Transportation employees and Outsourced contractors (Training)

FDA Good Documentation Practices (FDA GDP)

TGA Good Record Keeping / GDocP

For GMP consultancy and/or GMP audit assistance, validated quality management systems (QMS) and other data integrity or production engineering and distribution practice consultancy, visit PharmOut’s site.

You can also browse our top online GMP training courses for industry-specific training, available in bundles. Onsite custom courses by Maria Mylonas are also available at your facility anywhere in the world.

Page last updated: October 4, 2021.

(Video) Good Documentation Practices - GDP

FAQs

What are examples of good documentation practices? ›

Good Documentation Practice Standards
  • Analytical methods.
  • Batch manufacturing record forms.
  • Bills of materials (BOMs)
  • Calibration records.
  • Certificate of Analysis (CoA)
  • Certificate of Compliance (CoC)
  • Checklists.
10 Feb 2022

What are the requirements of good documentation? ›

Characteristics of good documentation
  • All relevant information must be recorded.
  • All paper records must be legible, signed and dated.
  • Records must be contemporaneous, accurate and kept up to date.
  • Records must be written in plain English avoiding jargon.

What are the principles of good documentation and record practices? ›

In the context of these guidelines, good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.

What is the GMP requirements for documentation? ›

Documents must be approved, signed, and dated by the appropriate competent and authorized persons. Documents must have unambiguous contents. The title, nature, and purpose should be clearly stated. They must be laid out in an orderly fashion and be easy to check.

What are the six principles of documentation? ›

If patient documentation is not timely, accurate, accessible, complete, legible, readable, and standardized, it will interfere with the ability of those who were not involved in and are not familiar with the patient's care to use the documentation.

What is meant by good documentation practices? ›

What Are Good Documentation Practices? 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.

What are the key characteristics of a document? ›

Validity: this document should be valid for a specific time. Writing Style: This document should follow standard and specific writing style. Accessibility: This document should be easy to use. structure: A document should have a structure that attract the user and seek their attention.

Why is good documentation practice important? ›

Leads to a smoother running operation, having complete information and knowing how to properly deal with issues. Reduces documentation errors by having the mechanisms to properly record data and correct errors. Maintains a level of consistency across an organization in how things are documented and recorded.

What are the five characteristics of good medical documentation? ›

6 Key Attributes of a Medical Record
  • Accuracy of the medical record. The accuracy of the data refers to the correctness of the data collected. ...
  • Accessibility of the medical record. ...
  • Comprehensiveness of data. ...
  • Consistency of information in the medical record. ...
  • Timeliness of information. ...
  • Relevancy of the medical records.
8 Apr 2013

What are the 9 principles for ensuring data integrity in documentation? ›

Let's look at each of the principles in more detail.
  • Attributable. To ensure collected, generated, or updated data is attributable, the following must be recorded: ...
  • Legible. ...
  • Contemporaneous. ...
  • Original. ...
  • Accurate. ...
  • Complete. ...
  • Consistent. ...
  • Enduring.

What is the main purpose of the document? ›

The purpose of a document is to facilitate the transfer of information from its author to its readers. It is the author's job to design the document so that the information it contains can be interpreted accurately and efficiently. To do this, the author can make use of a set of stylistic tools.

What are the 5 main components of good manufacturing practice? ›

5 Key Components of Good Manufacturing Practices
  • Primary Materials and Products.
  • Premises.
  • People.
  • Procedures.
  • Processes.
6 Jul 2021

What is GMP document control? ›

FDA regulations require GMP document control measures to ensure the integrity of SOPs, documents in the Design History File (DHF), batch records, employee training records, and similar documentation. The lack of GMP document control accounts for the majority of FDA Form 483s.

Which are the four tiers of documentation in ISO 9000? ›

The four tiers of ISO 9000 documentation are the Quality Policy Manual, Procedures, Work Instructions, and Records.

What are the 5 principles of documentation? ›

For documentation to support the delivery of safe, high-quality care, it should: Be clear, legible, concise, contemporaneous, progressive and accurate.

What are the standards of documentation? ›

Documentation Standard means the standard of quality and formatting of documents as stated in an Order. At a minimum all documentation created must meet or exceed applicable industry standards. Documentation Standard has the meaning assigned to such term in Section 3.04(2)(iii).

What are the methods of documentation? ›

Methods of Documentation
  • DAR (data, action, response)
  • APIE (assessment, plan, intervention, evaluation)
  • SOAP (subjective, objective, assessment, plan) and its derivatives including.
  • SOAPIE (subjective, objective, assessment, plan, intervention, evaluation).

What is a GDP in pharma? ›

Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.

Why is GDP important in pharma? ›

Not only can GDP help improve patient health outcomes, but it can also help address reputational, litigation, and financial risks for pharma manufacturers. This includes managing product recalls, reducing counterfeiting, or ensuring compliance with local permissions, among others.

What is GxP in pharma? ›

GxP is a general term used to describe the quality guidelines and regulations applied in the pharmaceutical industry. GxP is the abbreviation of “Good x Practice”. The “x” in GxP stands for the field the guidelines and regulations applied to.

What is document quality? ›

Document quality is the value of a document to its target audience.

What are the four qualities of records? ›

Based on this study the essential characteristics of records were identified as context, form, organization, structure and version/copy.

What are the three main types of records? ›

The following sections will provide general guidance on the disposition of 4 types of records: Temporary records. Permanent records. Unscheduled records.

How many types of document are there? ›

Each document has a specific importance. We have 15 types of documents. Some documents are very important for example Professional documents, Informative documents, Birth and marriage certificates.

What is documentation and its importance? ›

Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use.

What is GDP and GMP? ›

Good distribution practice (GDP) and good manufacturing practice (GMP) are quality standards and guidelines that have the same ultimate objective – to ensure medical device and pharmaceutical products are safe, meet their intended use, and comply with regulations.

What are the steps involved in proper medical documentation? ›

Here are three steps you can take to ensure your records meet the needs of patients and your organization.
  • Step 1: Set policy. Evaluate your documentation policy to ensure that it covers key points. ...
  • Step 2: Educate staff. It's not enough to simply put a policy in place. ...
  • Step 3: Follow up.

What are the steps in the medical documentation? ›

The basics of clinical documentation
  1. Date, time and sign every entry. ...
  2. Write your name and role as a heading and the names and roles of all others present at the encounter.
  3. Make entries immediately or as soon as possible after care is given. ...
  4. Be legible. ...
  5. Be thorough, accurate, and objective.
  6. Maintain a professional tone.
4 Nov 2017

What are the 5 principles of data integrity? ›

According to the ALCOA principle, the data should have the following five qualities to maintain data integrity: Attributable, Legible, Contemporaneous, Original and Accurate.

What are the 4 data integrity behavioral controls? ›

4 Simple Steps to Ensure Data Integrity in Quality Control Labs
  • Data Integrity. Many data integrity issues can be traced back to human error; therefore, ensure that data integrity starts with the user. ...
  • Understand your Process Workflow and Data Lifecycle. ...
  • Automate Data Workflows. ...
  • Review Data for Quality and Completeness.

What is Alcoa in good documentation practices? ›

It stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

What are three examples of poor documentation practices in patient records? ›

Sloppy or illegible handwriting. Failure to date, time, and sign a medical entry. Lack of documentation for omitted medications and/or treatments. Incomplete or missing documentation.

What is GMP date format? ›

GDP requirements are standard for all GMP records and documentation. For example, it is acceptable to record the date as either Day/Month/Year, or Month/Day/Year. However, certain organizations may choose to use only one of these formats in all company documentation.

What are GDP errors? ›

Avoid the most dangerous errors during GDP documentation:

Development information or creating results without performing the work. Backdating entries. Signing someone else's name to a document. Filling in blanks without explanation.

What are the four purpose behind documentation? ›

Although there are many explicit purposes for creating a scientific or technical document, there are four general categories: to provide information, to give instructions, to persuade the reader, and to enact (or prohibit) something.

How can you improve your documentation? ›

Improve Documentation in 5 Steps
  1. Minimize Passive Voice. Time for a quick grammar lesson: ...
  2. Use Catchy Headings and Bullet Points. People today are constantly inundated with content. ...
  3. Reduce Buzzwords and Acronyms. ...
  4. Invest in Visual Content. ...
  5. Organize Your Documents Appropriately.
7 May 2022

What is the full meaning of documentation? ›

Definition of documentation

1 : the act or an instance of furnishing or authenticating with documents. 2a : the provision of documents in substantiation also : documentary evidence. b(1) : the use of historical documents. (2) : conformity to historical or objective facts.

What are GAMP 5 guidelines? ›

GAMP® 5 aims to provide a comprehensive explanation of how pharmaceutical companies should validate their computer systems. In practice, this means that these recommendations apply both to the users of automated pharmaceutical products, as well as the manufacturers who create and market them.

What are 4 m of GMP? ›

The mainstay of GMP is the 4M principle; Men, machines, material and manufacturing premises. All these 4Ms are equally important.

What is ISO document control? ›

ISO document control procedures specify measures you can use to control quality assurance documents and satisfy the requirement to withdraw issued documents when they are obsolete and replace them as revisions are approved.

What documents need to be controlled? ›

These blank forms need to be controlled as documents, and then as records once they're completed.
...
Some examples include:
  • Electronic documentation.
  • Photos.
  • Drawings, diagrams and sketches.
  • Audio tapes and videotapes.
  • Product samples and defect samples.
  • Paint swatches for color matching.
  • Checklists.
  • Flow diagrams.

What are control documents? ›

A controlled document is any digital or hard-copy entity which is required by a company, a standards organization, or a regulatory agency to be managed within a tightly controlled process that maintains the integrity of the document's content through revisions.

What are the levels of documentation? ›

Levels of Documentation
  • Organisational Context Model [Level 0] More.
  • Process Map [Level 1] More.
  • Process Modelling [Level 2] More.
  • Task Analysis [Level 3] More.

What is document control in QMS? ›

A document control system strengthens the management of files and allows for compliance with regulatory and quality systems (QS) within FDA, ISO, EU, and more. It is the foundation of any quality, compliance, or regulatory process.

What is the importance of good documentation practices? ›

Good documentation practices helps to track changes, ensures easy reporting of any defects as well as promote continuous improvements to the processes that can be recorded real time.

What is Alcoa in good documentation practices? ›

It stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

What role does good documentation practice play in any validation project? ›

Good Documentation Practices are methods for recording, correcting and managing data, documents and records, to ensure the reliability and integrity of information and data throughout all aspects of a product's lifecycle.

Which date format is good documentation practices? ›

1.4 The preferred format for the handwritten date on documents is the format: 2 digit day, three character month, 4 digit year.

What are the 9 principles for ensuring data integrity in documentation? ›

Let's look at each of the principles in more detail.
  • Attributable. To ensure collected, generated, or updated data is attributable, the following must be recorded: ...
  • Legible. ...
  • Contemporaneous. ...
  • Original. ...
  • Accurate. ...
  • Complete. ...
  • Consistent. ...
  • Enduring.

What is documentation and its importance? ›

Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use.

What are the 3 main GCP principles? ›

Risk minimization. Subject's rights, safety, and well-being. Adequate drug information.

What are the 5 principles of data integrity? ›

According to the ALCOA principle, the data should have the following five qualities to maintain data integrity: Attributable, Legible, Contemporaneous, Original and Accurate.

What are the 13 principles of ICH GCP? ›

  • Ethics. ...
  • Trial risk vs trial benefit. ...
  • Information on the Medicinal Product. ...
  • Compliance with the study protocol. ...
  • Medical decisions. ...
  • Informed consent. ...
  • Confidentiality. ...
  • Good Manufacturing Practice.

Why good documentation practices is important in pharmaceutical industry? ›

Those working in the pharmaceutical and other healthcare sectors must have “good” documentation practices to ensure the integrity and reliability of data. 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.

What is GxP data? ›

GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage and distribution.

What is a source document GCP? ›

1. What is Source Data? The ICH-GCP Guideline defines 'source data' as: 'All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

What is GMP in pharma? ›

What is GMP? Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

What is a GDP in pharma? ›

Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.

What is SOP in pharma? ›

What is a Pharmaceutical SOP? Pharmaceutical Standard Operating Procedure (SOP) is a tested, verified, approved, and documented way of executing operations that form the pharmaceutical industry's basis. It provides step-by-step guidance for the personnel to perform a specific process.

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