Good documentation practices SOP

Good documentation practices SOP
Purpose
To describe the procedure for Good Documentation Practice.
Scope
The scope of this procedure for good documentation practices applicable to all departments and documents at ABC Limited
Procedure
Preamble  
As per GMP “if it is not written down, then it did not happen”. The documents provide the information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be.
Principle
Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents are used should be fully defined the Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic and photographic media
The main objective of the system of documentation utilized must be to establish, control, monitor and record all activities which directly or indirectly impact on quality of products.
Documents:
Organized form of data & information, revealing status of individual or several activities performed.
Documentation:

The process of generating data, reports and documents is called ‘documentation’.

Adequate, accurate and appropriate information with complete traceability in a document makes it complete documentation.
Basic Principle of GDP:

• Do it right the first time and every time.
• Read then understand and then act instead of acting with incomplete information.
• Never try to hide any wrong doing.
• Anything which is odd can be handled through deviation system but not a will full mistake.
• Do not do back dating signatures or entries in any document/logs.
• Back dating signatures are like signing on your own punishment document.
• Write entries in clear, legible, visible and readable handwriting.
• In case of any correction, cross out the information with single line so that original entries are seen.
• Write correct information and sign/date with reason for correction in “*” mark.
• Online entries and online review is the only aid to get rid of any data reliability issue.
• Write what you do and do what is written.
• Always follow the procedures and instructions written in the documents. 
• In GMP environment, document plays a very important role.
•  here are three types of documents used in pharmaceutical industry:
• Commitment Documents
• Directive Documents
• Data Collection Documents

Commitment Documents:

• These are the documents that represent corporate goals, expectations, standards, commitments and agreements.
• Commitments document includes Quality Policy, Master plans, Regulatory submission documents, Quality Agreement etc.

Directive Documents:

• These are the documents that provide directions. They are written to ensure that the commitments are fulfilled during routine operations.
• Directive document includes Master Standard Operating Procedures, Protocols, Specification, Manufacturing records etc.
• Data Collection Documents:
• These are the document that provides evidence to demonstrate that directive documents have been followed. These are written to facilitate the collection of raw data.
• Data collection documents includes logbooks, batch records, worksheets, Forms, Formats etc
• As a good documentation practice, Data collection document require raw data duly collected in a structured format and provide conclusive information in the form of report.
• Raw data is traceable information in the form of result output, equipment print outs, spectra, chromatograms etc.
• Record is a collection of raw data in a structured format, worksheet etc.
• Report is a document that provides conclusive information drawn from raw data and corresponding record such as Certificate of Analysis, Validation report, Investigation report etc.
• Directive and Data collection documents (including format) should be prepared in line with specific SOP.
• Their preparation, review and approval should also be in line with specific SOP on SOP with signature.
• All types of documents shall be reviewed periodically to ensure that they meet regulatory / customer expectation, correctly reflect current practices and for improvement.
• The outcome of the review shall be recorded and document shall be revised as per specific SOP for Change Control.
• All involved personnel shall be trained for handling and usage of documents.
• It is expected that all documents shall be clear, legible error free and shall have traceability.
• In case data collection documents are in a set, for adequate traceability reference of set may be given, e.g. In analysis of multiple batches, set of all standard chromatograms may be attached with first batch and reference of such attachments shall be written on other batches analyzed in same campaign.
• Raw data, records and reports shall be duly signed and dated.
• In case of manual recording, all personnel shall avoid errors and / or mistakes during data entry.
• Forms, Formats, logbooks shall be filled / written adequately in provided space. In case of inadequate space, use asterisk (*) or other global characters (#, $, @ etc.) and write the details in footnote. No lines should be left blank. No column should be left blank. Use "NA for Not applicable.
• No page should be left blank. Partially utilized page shall be scored off after last entry followed by signature and date.
• In case any error is occurred, it has to be corrected as per defined procedure.
• Following Practices shall be followed for restriction of usage of unauthorized documents in GMP area.

• Page to be used for any data recording shall have format number and should be governed through concerned SOP or Protocol.
• Blank page shall not be used for recording.
• All deviations/incidents shall be handled through proper QMS and shall not be registered/logged/recorded on rough page or book.
• Personal notebooks shall not be used in working areas.
• Reconciliation of all issued and retrieved documents shall be maintained.
• Retrieved or obsolete documents shall be destroyed by shredding only. Papers shall not be torn into pieces.
• No documents shall be shared with customers or external party without justification and prior approval from QA.
• Documents shall be shredded after completion of retention period only.
• All logbooks shall be preprinted, bounded and paginated
• Logbooks and formats shall be issued by authorized QA person.
• Approved specimen copies of all required forms/formats shall be available with authorized  QA documentation team in specific drive with limited access.

Do's and Don'ts for Documentation:

For good documentation practices, following do's and don’ts shall be followed, but not limited to:

Do’s

• Use controlled sheets, numbered & bounded notebooks for recording data.
• Enter detailed, complete and accurate information at the time work.
• Date should be written as (DD/MM/YYYY) e.g. 01/01/2018.
• Put signature or initials with date (DD/MM/YYYY) on real time basis.
• QA will use “Blue Ballpoint” Pen and rest all departments will use “Black Ballpoint” Pen.
• Limit the use of abbreviation and acronyms.
• Unused pages in documents should be cut off or cross- out signed with date.
• For operational purpose and or wherever time need to be recorded, record the activities in 24 Hour time format.
• Extra lines or columns, if applicable shall be clearly defined as 'Not Applicable’ or NA.
• Correction of raw data must be performed, a single line in ink through the error. The original entry should still be legible.
• Record the correct entry on the documents above or next to the original entry and put the initial /date for each entry.
• Avoid generation of any extra printout during master generation, analysis, and reporting and review activity. In case if extra printout is generated then it should be written as “INVALID” and reason/justification should be written and then same should be filled with analytical docket
• If initial print out is not clear or legible then extra print out should be taken and initial printout should be written “INVALID” and reason/justification should be written and then same should be filled with analytical docket.
• Raw data on thermal paper might fade away with time therefore a photocopy of thermal paper shall be retained.
• In case if any additional print is required for other purpose like audit/for Vendor/which is not going to attach with analytical docket then it should be generated only against appropriate request and approval from concern supervisor and/or department in charge or designee.
• These kind of print outs should be handled as per SOP on SOP.

Don’ts

• Don't over write any document.
• Don't use pencil / ink pens for documentation.
• Don't use erasers / correction fluids for correction of documents.
• Don't use loose papers / 'post it notes' for documenting data.
• Don't use uncontrolled documents for data entry.
• Don't leave lines or columns without entry.
• More than two cutting is not allowed in one page 

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