QMS-165 Good Documentation Practice

1.0 DOCUMENT OWNER

Technical/Quality Manager

2.0 PURPOSE

Good documentation constitutes an essential part of any quality system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history.

The purpose of this SOP is to provide guidelines and establish rules for documentation practices at the GMP site.

3.0 SCOPE

This procedure applies to all documents within the GMP facility relating to the manufacturing, processing, packaging, storing, testing and controlling of pharmaceutical products, components and raw materials. This includes documentation relating to equipment and validation.

4.0 RESPONSIBILITY

4.1 Responsibilities                        

It is the responsibility of the site quality team to ensure that the requirements of this SOP are followed.

It is the responsibility of all Department Managers / Designees to train employees on this procedure and monitor compliance during the review and verification of documents.

It is the responsibility of each staff member to follow the requirements of this SOP.

4.2 Training

Before carrying out this procedure, operators must have successfully completed GMP Training modules such as “Introduction to GMP” and “Documentation and Record Keeping” where available.

Operators will be trained by a trained person in this Standard Operating Procedure (SOP) and this is to be documented in the Staff Training Records. The trainer will demonstrate the procedure involved in undertaking tasks associated with this SOP. This may involve several interactive demonstrations between trainer and trainee.

Retraining in this SOP is required at least every 3 years unless this SOP is updated to a new edition.

5.0 PROCEDURE

5.1 General Requirements

5.1.1 All handwritten entries are in black or blue permanent ink. Felt tip pens, fountain pens, pencils, etc., are NOT permitted.

5.1.2 Never use erasers, white out, labels, correction tape, multiple cross outs or any other method that obscures any recorded information or entry.

5.1.3 All original data must be kept and available for review.

5.1.4 All entries must be easily read; one cannot misinterpret the entry.

5.1.5 Document at the time the action occurs.  POST or PRE-DATING is NOT allowed.

5.1.6 Only original documents stamped in red are used to make copies, e.g. forms; do not make copies of copies.  

5.1.7 Signature / Initial List – All personnel involved in handling GMP documentation are required to register their signature and initial.

5.1.8 When writing documents, abbreviations should be defined the first time they are used.

5.1.9 Master documents cannot be changed by a cross-out and initialing unless approved by Quality Operations.

5.1.10 Ensure that entries are consistent in the use of terminology, dates and units of measures.

5.1.11 Record all data on the official document(s) – do not write on scrap paper, clothing, skin or post-it notes, etc.

5.1.12 All times should be recorded clearly following the required format(s) in Section 5.3.2.

5.1.13 Do not use ditto (“) mark as an entry.

5.1.14 Use only documents that are approved and effective.

5.2 Writing Notes or Comments

5.2.1 Initial and date all notes and comments. Comments must be able to stand on their own and not be subject to interpretation.

5.2.2 Record only facts and observations in a document’s written explanation(s).

5.2.3 Be clear and concise.

5.2.4 Do not include opinions or comments unrelated to the document.

5.2.5 Do not make random notes, random comments, or stray marks on any document.

5.3 Format for Date and Time Entries

5.3.1 The following is the date format for use when making handwritten entries in a document. All of these examples are acceptable. Some documents have specific format requirements that may overrule this recommended format, e.g. document for submission to countries that require the month/day/year format.

i. DD-MM-YY, e.g. 02 March, 2022 = 02-03-22

ii. DD/MM/YY, e.g. 02 March, 2022 = 02/03/22

iii. D-M-YY, e.g. 02 March, 2022 = 2-3-22

iv. D/M/YY, e.g. 02 March, 2022 = 2/3/22

v. DD/MMM/YYYY, e.g. 02 March, 2022 = 02 MAR 2022

vi. DD/MMM/YY, e.g. 02 March, 2022 = 02 MAR 22

5.3.2 The time format may be either of the following:

– AM/PM, e.g. 8:00AM

– 24-Hour clock, e.g. 0800 for 8:00AM or 2000 for 8:00PM.

Note: Same time format should be used within a document. 

5.3.3 When recording time, do not use fractions. For example, 30 minutes or 0.5 hours instead of ½ hour.

5.4 Initials

5.4.1 Use initials and signatures consistently on all cGMP documentation. Always use the initials and signatures you provided on the Signature and Initial list.

5.4.2 Signature (or initials) on cGMP documentation indicates who performed or approved the information in the step and/or document.

5.5 Handling Blank Spaces

5.5.1 As a general rule, blank spaces are not permitted on completed documents. If an entry does not have to be made in a specific instance on a document, use the notation “N/A” meaning (Not Applicable).

Note: N/A refers to “Not Applicable”. No other acronyms should be used unless explained. “Not Available” or other notations should be fully spelled out.

5.5.2 If an entry space does not have a data entry because it is for start-up or end of production, then a phrase “Start Up” or “End of Production” or similar phrase, is used.

5.5.3 If a table or most of a table is left blank, include a single diagonal line across the blank part of the table (from bottom left to top right or from top left to bottom right); write N/A and initial and date.

5.5.4 If a narrow cell in the table is left blank, putting N/A in the cell is enough there is no need to sign and date due to space constraints.

5.5.5 If instructions are given to skip a step, or portion of a step, line through that portion, initial and date.  No explanation is necessary, because the explanation is supplied within the documentation instructions.

5.5.6 All written comments must be dated and ininitialed

5.6 Data Entry

5.6.1 Only record data directly onto the official document.

5.6.2 Do not transfer data from unofficial sources, i.e. scrap paper. Transferring information from qualified / validated system is acceptable, i.e. inventory control system, deviation, etc.

5.7 Timing of Corrections / Changes

5.7.1 If the correction is made immediately after the incorrect entry, make appropriate corrections, provide an explanation if necessary and sign / initial and date the correction.

5.7.2 If the correction is made not on the same day the incorrect entry was made, make the appropriate corrections, provide an explanation and sign / initial and date the correction on the day it was made.

5.7.3 If the correction is made by a staff member other than the person who performed the action, make appropriate correction, provide an explanation, sign / initial and date the correction on the day it was made and have supervision verify this action.

Note: This should only be done if the staff member who performed the action is unable to return to work.

5.8 Making a Correction / Clarification

5.8.1 Perform all entry corrections so as not to obscure the original entry.

– Repeated lines through an original entry is not permitted.

– Use of erasers and correction fluids is not permitted.

5.8.2 Draw a single line (strike through) the entire entry to be corrected.

5.8.3 Record the correct value or information.

5.8.4 Initial and date (current) the correction.

5.8.5 Provide an explanation for the correction.

5.8.6 If space does not allow the correction or the correct information to be placed next to the error in the document:

– Provide a notation next to the correction, initial and date.

– Place the corresponding notation within the document where space is available, e.g. bottom, margin, back of the page.

Example:

03/03/22* 03/02/22,

*Incorrect date entry. DB 03/02/22.

where “DB” is the staff member.

5.8.7 Cross-reference original page and step (if available), if a comment is made on a different page, e.g. Comment section, etc.

5.8.8 Data omissions may be corrected at a later date by adding the correct entry, initialing for the addition and applying the current date for the date that the data should have been added.

It should be apparent that the entry was made after the fact. If there is an original source for the data, a notation should be added as an explanation.

5.8.9 If a correction is made to a record after its approval then a re-approval is required. Example: Correction made on a shop order after approval of Expiry date from QA.

5.9 Use of Printouts and Other Additional Documents

5.9.1 All pertinent printouts are included in the official documents, i.e. scale / balance printouts, temperature charts, etc.

5.9.2 All printouts are signed / initial and dated, contain the ID number of the instrument, location of the instrument, if portable, and lot number and product name or product code associated with the printout.

5.10 Use of Copies

5.10.1 Only use an original to make copies. DO NOT make copies from a copy.

5.10.2 Copies of Standard Operating Procedures are provided by the Document Control Officer.

5.10.3 Copies of batch record documentation, e.g. Manufacturing Instruction and Packaging Shop Order etc., are issued by the Planning Department using the “Batch Document Management System”.

Manufacturing Instruction and Packaging Shop Order must be auauthorizedy Manufacturing Compliance, Production and Quality Assurance.

– If additional copies are needed, the Planning Department will reissue the document(s) needed.

– The original issued document must be kept with the batch documentation with appropriate annotations provided.  The reason for the re-issuance must be given.