Introducing SOP on Good Documentation Practices (GDP). All pharmaceutical industry follows the good documentation practices for the consistency in documentation. This SOP is helpful to understand how the GDP plays an important role to minimize data integrity by following the ALCOA+ principle. The purpose of good documentation practices procedure to maintain data integrity. This SOP is helpful for the correlation of good documentation practices and data integrity.
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| SOP on Good Documentation Practices (GDP) |
1.0 PURPOSE:
To provide implementation of the Good Documentation Practices (GDP). GDP is applicable every time and everywhere in pharma during documentation. Principles of Good Documentation Practices are to achieve the accuracy, reliability, consistency, readability of data.
2.0 SCOPE:
Applicable for every documentation process including preparation, checking, modification, reviewing, correction, approving of all Quality documents.
3.0 RESPONSIBILITIES:
Every employee/worker/co-worker (all departments) involved in the preparation, checking, modification, reviewing, correction, approving of all Quality documents.
All employee ensure that documentation practices follow should be secure, attributable, legible, contemporaneous, original, accurate, traceable, permanent, and recorded and as per cGMP norms (ALCOA+).
4.0 DEFINITIONS:
4.1 Raw data
Raw data is original data generated the first time electronically or manually.
Refer for more details of Raw data, Metadata, and Source data.
4.2 Good documentation Practices
Measures were taken to ensure documentation practice collectively or individually for manual or electronic documents. Documentation practices should be secure, attributable, legible, contemporaneous, original, accurate, traceable, permanent, and recorded (ALCOA+).
5.0 PROCEDURE:
5.1 Recording of data (Data Entry)
5.1.1 Every employee must follow ALCOA+ system i.e Attributable, Legible, Contemporaneous, Original, Accurate, enduring, available, consistent, complete during documentation.
5.1.2 Maintain the accuracy of the documents and records should be free from errors.
5.1.3 Data should be recorded online (contemporaneously). There is no delay while recording the data.
5.1.4 Temporary documentation of data is not allowed.
5.1.5 Records must not be pre-dated or post-dated.
5.1.6 During filling the documents never use Ditto marks or sign (“).
5.1.7 Falsification and manipulation of data or records are not allowed.
5.1.8 Handwritten entries should be done with permanent ink (blue ball pen). Pencil and gel pens are not allowed.
5.1.9 All entries should be checked and verified for accuracy and completion.
5.1.10 Do not kept any space blank on the documents. Fill the appropriate field on the documents and if any space not needed to fill in such a situation a field can be marked as Not Applicable or NA or N/A.
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Sr. No |
Tests |
Results |
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1 |
pH |
4.51 |
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2 |
Melting point |
NA or N/A |
5.1.11 If any whole page kept blank then cross the page from top of left to right of bottom. In the middle write NA or N/A and at bottom of the right sign and date of recorder.
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| Use of Not Applicable, NA, N/A, Good Documentation Practices (GDP) |
5.1.12 Violation of data integrity principle or Good Documentation Practices should be handled through a Quality Management System (QMS) like deviation, DCR, etc.
5.1.13 Enter data or indicate completion only for the activities which are performed.
5.1.14 Do not generate data without performing the actual activity.
5.1.15 Data must be generated by the person according to the role he/ she played during activity.
5.1.16 Quality records should be documented in standard formats, protocol attachments, checklists or Instrument logs.
5.1.17 Only use the current version of the form/ protocol to record the quality records.
5.2 Date and Time Format
5.2.1 DD/MM/YY format is used
Where,
DD – the day of the month,
MM – the month
YY – the year,
E.g. 16/10/20 indicates 16th October 2020.
5.2.2 Format of date is applicable to all types of documentation.
5.2.3 Other date formats acceptable only for uncontrolled format system of computerized systems.
5.2.4 HH:MM time format acceptable only.
Where,
HH – Hour 24 hours clock.
MM – minutes of clock.
E.g. 1.00 PM is written as 13:00
5.3 Initial and Signature system
5.3.1 Initial or signature should be unique and identifiable.
5.3.2 The person responsible for making entries or generating original data should sign the documentation in a way that clearly identifies the person responsible for the activity and/or entry and when they made that entry or observation.
5.3.3 This is applicable for prepared by (Doer), checked by, verified by, reviewed by, approved by.
5.3.4 The signature requirement also applicable for an individual person who writing “Comments” or “Justification”.
5.3.5 A the handwritten signature is indicating the accountability or responsibility of the individual person.
5.3.6 Specimen the signature log should be maintained for all persons working in the organization.
5.3.7 Persons should be only sign and date for the work which they completed or responsible and authorized to sign.
5.3.8 A the signature log shall be maintained by the training department, which contains the individual’s name, signature both full signature and unique initial (short signature)
E.g.
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Good Documentation Practices (GDP), Short and full signature
5.3.9 After completion of signature log process person cannot allow using different full signature and unique initial.
5.3.10 If any person required to change his/her full signature and unique initial, then first, inform to training department and with proper justification, a person can change significantly in the signature log.
5.3.11 Electronic signatures or e-signature is a combination of user name and password that represent a person’s handwritten signature.
5.4 Numerical Values system
5.4.1 Numerical results consider single-digit, double-digit, and triple digits as per tests:
5.4.1.1 Single-digit: Assay results e.g. 99.6 %
5.4.1.2 Double-digit: LOD, Residue on Ignition, Impurity tests E.g. 0.02 %
5.4.1.3 Triple-digit: Heavy metals, Limit tests E.g. 0.002%
5.4.2 Rounding rule applies to reduced digits of the results obtained. This rule mostly used during the calculation of the analytical results.
5.4.3 If the last digit to the right of value is less than 5 then do not change the number next to the last digit.
e.g. If the calculated value is 2.9264 then as per the Rounding rule for 2.9 for a single digit, 2.93 for double digits and 2.926 for triple digits.
5.4.4 If the last digit to the right of value is greater than or equal to 5 then increase the number next to the last digit.
E.g. If the calculated value is 2.8667 then as per the Rounding rule for 2.9 for a single digit, 2.87 for double digits and 2.867 for triple digits.
5.5 Data/Error Entry Correction
5.5.1 If any error occurred while reporting, calculation or filling the data/documents this entry should be corrected as per below procedure:
5.5.2 Corrections should be made only by the responsible person that made the original entry.
5.5.3 Whenever required re-verify the changes or corrections by a second person.
5.5.4 Reapproval required if changes or corrections are made after approvals.
5.5.5 If original/raw data is not saved as evidence, report to the QA department or immediate supervisor, and file deviation.
5.5.6 If any mistake or error is made on a record or data then strike the horizontal line on original or wrong entry, write the correct entry with sign and date and provide justification/reason/remark/note for correction. Wrong entries should not be erased or overwritten.
E.g.
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Good Documentation Practices (GDP), Entry Correction method
5.5.7 Partial entry correction is not allowed.
E.g.
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Partial entry correction, Good Documentation Practices (GDP)
5.5.8 If any mistakes or errors are found during the review with original, processed, or metadata then communicate with the recorder or doer.
5.5.9 If minor mistake found during a review like calculation error, reporting results etc. then correct it as per point no. 5.5.6 on the date when it found to the reviewer.
5.5.10 If error is major or abnormal showing inconsistency then file deviation or nonconformance.
5.5.11 Never use correction fluid (Whitener or any other thing) while correcting the wrong entry.
5.5.12 Never alter original data without proper justification.
5.5.13 If correction in original or raw data results which are directly related to the passing limit then the second person verifies the correctness of results.
E.g. limit range 1.25 to 1.55 recorder reported the result as 1.65 instead 1.45 which out of limit. In such a case the second person verifies the reported value.
5.5.14 Never correct printed data like BMR, BPR, Protocols, formats, etc. If any correction or change required then handled through the QMS system with proper justification on change printed data.
5.5.15 In case error found but doer/performer/recorder is not available at the time of correction then another authorized person can able to sign.
5.5.16 Correction of electronic data:
5.5.16.1 Audit trail requirements for computer-based electronics systems.
5.5.16.2 Electronic record should be considered as a true copy or original record (raw data) generated the first time and stored in a secure format (PDF) in a validated system.
5.5.16.3 Wrong entries should not be erased or deleted from the electronic system.
5.5.17 If any change required in electronic data then clearly mentioned who, what, when, why change is done.
5.5.18 In case of multiple-choice options available on a document then the preferred mode for selection is a circle.
E.g.
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Good Documentation Practices (GDP) for multiple-choice option
5.6 Signature of Quality Document in case of out of office
5.6.1 In case of any emergency for completion of the document.
5.6.2 Send the respective document to the person.
5.6.3 Responsible/Authorized person take a print of the document.
5.6.4 Signature and date have done by a person using a blue ball pen (permanent ink).
5.6.5 Scan the document into a PDF format and send it back to the organization.
5.6.6 This same scan page submitted to the organization, whenever he/she will reach at the organization to maintain transparency.
5.7 Disposal of documents:
5.7.1 If any person required to destruct extra copy, draft copy, reference copy then record the details in “Documents Destruction Record” and this record approved by respective HOD.
5.7.2 After approval of destruction record, shred the documents in the shredder in proper manner.
5.8 Indentification and traceability of documents:
5.8.1 All records should be traceable and should have a unique identification number contains organization code, department code, serial number, etc.
5.8.2 Attachments, standard format, the exhibit should contain a referral unique number to trace the documents. E.g. Refer SOP on SOP numbering system. Whenever required attached the documents for traceability.
5.8.3 Confidential documents mentioned as “CONFIDENTIAL”.
5.9 Adding information to record
5.9.1 If required to add some details on documents then handled through the QMS system with proper justification.
5.9.2 If the information is added after approvals then the record should be reapproved.
5.10 Record completion date
5.10.1 The completion date of a record is considered as the latest date entered on the completed record.
5.11 Re-writing
5.11.1 Re-writing should be applicable if the wrong format used.
5.11.2 Approval is required from HOD for the prior to rewriting the documents with proper justification.
5.11.3 Rewritten copy should be verified with the original and comments as “Rewritten and Verified”.
5.11.4 After rewriting keep the old page with a new page for traceability and reliability of data.
5.12 Email usage and verbal approval
5.12.1 Printed copy of E-mail considers as a record when it is signed and dated by the sender.
5.12.2 E-mails that are used to support a study can be printed and attached to a record or kept with study-related materials.
5.12.3 E-Mails can be considered as GMP record only if it is generated to satisfy a GMP requirement, and must include signature and date.
5.12.4 E-Mails can be considered as verbal approval if there is a situation that is part of non-conformance and HOD/designee not available. Then HOD/designee writes details about the non-conformance and justification for that situation. E-mail receiver from site sign and date the printed e-mail copy.
5.13 Below some points/examples of falsification of data:
5.13.1 If any activity remained during working and it finds out later than don’t do any false entry of that remaining work. Immediately notify Quality or immediate Supervisor.
5.13.2 Before performing the activity do not report or fill in the data.
5.13.3 Record the data with sign and date by the person who is responsible for that activity.
5.13.4 Never sign the activity performed by another person.
5.13.5 All a person should be sign and date on data or documents who are involved in the activity.
5.13.6 Entry of backdating on the present date and advance date on the present date should not allow.
5.13.7 Electronic signatures are equivalent to a handwritten signature. So, do not share your user name and password with another person. It’s a violation of GMP and considers the falsification of data.
5.14 Documents cover under GDP but not limited:
5.14.1 Batch manufacturing record (BMR)
5.14.2 Standard Testing Protocols (In-process, Raw material, Finished product, Stability, etc.)
5.14.3 Batch Packing record (BPR)
5.14.4 Training records
5.14.5 Logbooks
5.14.6 Validation Records
5.14.7 APQR (Annual Product Quality Review)
5.14.8 Vendor Records
5.14.9 Standard Formats
5.14.10 Internal Audit Reports etc.
6.0 ABBREVIATION
DCR – Document Change Request
QA – Quality Assurance
GDP – Good Documentation Practices
SOP – Standard Operating Procedure
cGMP – current Good Manufacturing Practices
LOD- Loss on Drying
QMS – Quality Management System
7.0 REFERENCES
7.1 CFR Part 820, Quality System Regulation
7.2 CFR Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals
7.3 ISO/DIS 9000, Quality Management System-FundamentalsVocabulary
7.4 EudraLex Volume 4 Good Manufacturing practice for MedicalProducts, Chapter
7.5 PIC/S Guide to GoodManufacturing Practices for Medicinal Products, Part I, September 2009
7.6 MHRA – Examples of issues with remote approval (April 2020 -Working from home guidance)
8.0 HISTORY
Not Applicable
9.0 ANNEXURES
9.1 Documents Destruction Record
FAQ:
1. What are good documentation practices standards?
Some standards to be maintained during GDP like documents should be accurate, reliable, contemporaneous, readable, original, attributable, available, enduring, complete, consistent, traceable, recorded, etc. Measures were taken to ensure documentation practice collectively or individually for manual or electronic documents is good documentation practice.
2. What is the purpose of good documentation practices?
GDP is applicable every time and everywhere in pharma during documentation. Principles of Good Documentation Practices are to achieve the accuracy, reliability, consistency, readability of data. Good documentation practice is helpful to maintain the uniform practice for data recording, build trust in data, avoid confusion, easy understand the recorded data,
3. What does GDocP stand for?
GDocP is an acronym that specifically stands for Good Documentation Practices. GDP stands for Good Documentation Practices as well as Good Distribution Practices. To avoid confusion between Good Documentation Practices and Good Distribution Practices. Good Documentation Practices are introduced with the new acronym GDocP .
4. What is the cGXP standard for drug documentation?
cGXP stands for Good ‘X’ Practices. ‘X’ covers manufacturing, laboratory, engineering, distribution, documentation, safety, clinical, business, agricultural, financial, hygiene, auditing, personnel, etc. For documentation GDP or GDocP (to avoid confusion between documentation and distribution) acronym is used.
5. What is the good documentation practice in GMP?
As per WHO-GMP, Good documentation is an important part of the quality assurance and GMP. It helps to decide the SOPs and specifications for all materials and control. The person working in the manufacturing area should know how to do this work, what to do, when to do it.
The person who is going to release the finished product should verify the information about that product such as raw data, audit trail, report, etc, and these reports are attached with existing documents as evidence. Manufacturers decide the design and use of documents.