What is Document:
A piece of written, printed, or electronic matter that provides information or evidence or proof of any activity that serves as an official record.
Why Good Documents are Required in Pharmaceuticals :
1.If it isn’t documented, it didn’t happen & we document to provide written proof that something happened.
2.For regulatory requirements & business reasons- intent of making quality product or cost saving improvements.
3.To Compliance with the Food and Drug Administration’s (FDA), Good Laboratory Practices, regulations (21 CFR Part 58), as well as GMP (Good Manufacturing practices) regulations for drugs and medical devices (21 CFR Parts 211 and 820) requires the use of Good Documentation Practices.
4.Good Documentation Practices (GDP) apply to everyone who documents activities related to cGMP (Current Good Manufacturing practices).
5.A key to Good Documentation Practices is to consider these questions each time you record your raw data:
a. is it true? c. Is it timely?
b. is it accurate? d. Is it legible?
What is Good Manufacturing practices (GMP) :
It 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 Current Good Manufacturing practices (cGMP) :
The letter “c” stands for “current,” reminding manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation.
What is Standard Operating Procedure (SOP) :
A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization.
Instructions to be followed for Good Documentation Practices (GDP) in Pharmaceuticals :
- Write what you do, do what is written
- Document shall be made clearly, readable, legible, accurate, prompt & consistent with water proof, nonfadable writing instrument, so that information cannot be erased or changed & easy to understand.
- All documents / data should be written, signed and dated with permanent ink pen.
- Date shall be written on the documents in the pattern of DD/MM/YY or DD/MM/YYYY & For the time, use 24 hours clock. No AM or PM shall be used. Time format shall be as HH:MM and wherever applicable time format shall be as HH:MM:SS.
- Any mistake while recording the data during operation should not be corrected with “Whitener”, “Eraser” and “Overwriting” on the same.
- In such case the wrong word is to be cancelled with horizontal cut line or striking-off the single line (i.e. Wrong) and rewrite the correct word with ink pen.
- After cancellation and necessary correction the concerned person should put the valuable reason (if applicable) with signature and date. The reasons such as entry error, calculation error, printing error, transcription error, typographical error etc. can be used as applicable and as suitable. If sufficient space is not available for writing the reason, correction shall be numbered sequentially from 01 and the same shall be described at bottom of respective page by concerned person with signature and date.
- Document entries should be done only by authorized person for that operation & don’t use pencil for writing the documents / data.
- Where the Ink Jet / Ribbon / any other Printer are used for presenting the data (Computer generated Report), the printing must be dark, clear, readable All computer generated reports must be reviewed, signed and dated.
- Preferably, documents shall be prepared on “A4” size paper i.e. for Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR), Analytical Work Sheet, Qualification Documents, Validation Protocols, or other cGMP Documentation.
- Photocopy of any document without stamp shall be considered as “Uncontrolled Document”.
- Use of thermal paper for printing / documentation is to be avoided. Wherever required for printout, clear photocopy duly signed and dated shall be attached.
- “Ditto Marks” (—-”——-) shall not be used for documentation.
- “Bracketing” shall not be done for documentation.
- In case issued document requires entry of additional data, information / addition of text matter which is not provided in the document, same shall be written legibly and shall be initiated by the person making the entry.
- Whenever more than one option is available, encircle / tick the option which one is applicable. e.g. Batch Manufacturing Record, Analytical Worksheet etc.
- The Standard Operating Procedures (SOPs) shall be prepared to make the work simple, understanding the subject and for systematic working.
- The “DISPLAY COPY” of the Standard Operating Procedures should be available in the designated area / near the Equipment and Instrument.
- In case of any Change / Clarity / Amendment related to procedure / practical applicability as mentioned in Standard Operating Procedure, consult the concerned Supervisor / Department Head.
- Always follow the procedure mentioned in the Standard Operating Procedure for effective and good documentation.
- If required, a remark shall be entered for any incorrect entries by the concerned Operator / Supervisor.
- Always maintain online documentation First perform the activity and then immediately document the same to achieve error less document.
- Always use Approved / Current Formats / Data Sheets for recording data.
1. Don’t use any other method or procedure in place of the written approved procedure (Discuss in case of a better way of executing the procedure with the concerned Supervisor / Department – Head and implement only on revision of the SOP).
2. Don’t by pass any step of the Standard Operating Procedure to make work easy.
3. Don’t document the activity before or without performing the activity.
4. Don’t keep any column blank, all cell provided for the recording of data shall be filled. When a particular point is not applicable it should be written as “NA” in the space provided for the data entry and “Nil” in case of quantitative data entry not required, use of dash (–) is prohibited. If there is any blank space after recording the data on a paper, it has to be cancelled by striking off line ( \ ) from left top corner to right bottom corner with “NA” followed by sign & date.
5. Don’t write any details in a chit of paper or palm.
6. Don’t write any record (cGMP Document) in vernacular language.
7.Don’t handle documents in an unsystematic way.