Standard Operating Procedure: Good Documentation Practice

1. Purpose

To define the common practice to be followed for data entry in all GMP / GLP records.

2. Scope

This procedure is applicable to all GMP / GLP records filled manually at Pharmaceutical Limited. This SOP is a general guideline and will be superseded whenever any specific requirements are mentioned in other SOP or approved documents.

3. Definitions / Abbreviations

• GMP / GLP Records: All records which directly or indirectly and individually or collectively control the strength, identity, safety, purity, and quality of drug products.
• Annotate: To add explanatory notes.
• SOP: Standard Operating Procedure.
• N/A: Not Applicable.

4. Responsibilities

5. Revision Details

6. Procedure: General Guidelines

• Sign and date all data entries on the date of data entry, as applicable.
• Date to be written numerically in the DD/MM/YY form.
  E.g., 13/01/15 for 13th January 2015.
• Time to be written numerically in the HH:MM form using a 12-hour cycle daily.
  E.g., 8:30 AM, 4:30 PM etc.
• Time duration to be written as: 2min 30 sec (Not as 2:30min).
• In case of wrong entry, strike out with a single line and put initials and date nearby it. Do not overwrite or block the wrong entry.
• Do not leave blank space. Write N/A.
• Do not use " " (ditto marks) if the entry is repeated in the next line.
• Use of pencil is not allowed. Correction fluid, white ink, or erasers should not be used.
• Entries must be made in legible handwriting.
• Unusual observations shall be recorded, signed, and dated.
• Entries in logbooks shall be done in chronological order.

General Guidelines for using Indelible Ink Pen:

• Write all GMP records only with Permanent BLUE indelible ink pen.
• Permanent BLUE indelible ink pen should be used for signing master documents.
• The QA supervisor should use a Permanent GREEN indelible ink pen to sign after checking data on the shop floor.
• Data entries should be recorded, signed, and dated immediately after the completion of each activity.

7. Correction of Recording Error / Overwriting

In case of any wrong entry, do not overwrite or block the entry to make it obscure. Strike out the wrong entry with a straight single line so it remains readable. Make the correct entry nearby.

If space is not sufficient, use an asterisk (*) nearby and define it at the bottom of the page with the correction, initials, and date.

8. Entry of Missed Step

Entry of any missed step can be done later only if it can be proved that the step was performed. The person making the entry shall put initials and the current date nearby.

9. Working with Blank or Unused Space

Do not leave blank space in any GMP record. Strike out any blank space or page with a cross line and write N/A with initials and date.

10. Rounding off of Values

• Rounding off is applicable only to calculations, not to observed readings.
• Limits which are fixed numbers shall not be rounded off.
  E.g., If limit is 2-8°C, an observed value of 8.2 cannot be rounded off.
• Any value displayed by an instrument (e.g., pH meter showing 3.79) should be recorded as is.

Rounding Rules:

• If last digit is ≥ 5, eliminate it and increase the preceding digit by one.
• If last digit is < 5, eliminate it and the preceding digit remains unchanged.

Table 1: Illustration of Rounding Numerical Values

11. Assigning Due Date

Calculate the due date as per the frequency from the day the activity is performed. Status remains valid up to the due date.

Example: Pre-filter cleaning on 01/01/15 with 15-day frequency. Due date: 15/01/15.

12. Quality Control Laboratory Practices

• 'Complies/Does not comply' is allowed for binary observations only, but must be specific (e.g., mention observation in Limit test).
• Calculations shall be documented.
• Concordance of another analyst is required for subjective tests (e.g., TLC plates). Both analysts shall sign.
• Instrument printouts must be retained, even if not used in calculations.