Good Documentation Practice, Purpose:
Good Documentation Practice, To define the common practice to be followed for data entry in all GMP / GLP records.
Good Documentation Practice, Scope:
This procedure is applicable to all GMP / GLP records filled manually at XX Pharmaceutical Limited (Both General & Sterile Block). This SOP is general guideline and will be superseded whenever any specific requirements are mentioned in other SOP or approved document.
Definitions / Abbreviation:
[][]GMP / GLP Records: GMP / GLP records are defined as all records which directly or indirectly and individually or collectively control the strength, identity, safety, purity and quality of drug product.
[][]Annotate: To add explanatory notes.
[][]SOP: Standard Operating Procedure.
[][]N/A: Not Applicable
Responsibilities:
[][]The roles and responsibility is as follows:
Concerned Personnel
[][]To carry out the documentation as mentioned in SOP.
Department Head or Designee
[][]To ensure training and implementation of SOP.
Manager, Quality Assurance
[][]To ensure implementation of SOP.
Procedure: Good Documentation Practice
[][]General Guidelines for documentation practices:
[][]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. write 13/01/16 for 13th January 2016.
[][]Time to be written numerically in the HH:MM form in the document using 12 hours cycle daily. For e.g., 8:30 AM, 4:30 PM etc.
[][]Time duration to be written as shown below:
[][]e.g. If for some process the observed time duration is 2 minutes and 30 seconds then it’s should be written as 2min 30 sec and not as 2:30min.
[][]In case of wrong entry, strike out with single line and put initial and date nearby it. Do not overwrite or block the wrong entry.
[][]Do not leave blank space, Write N/A.
[][]Do not use the ” if the entry is repeated in next line.
[][]Use of pencil is not allowed.
[][]Correction fluid / white ink / eraser should not be used.
[][]Entries to be made in legible handwriting.
[][]Unusual observations shall be recorded, signed and dated.
[][]Entries in logbook shall be done in the 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 of master documents.
[][]The QA supervisor should use the permanent GREEN indelible ink pen to sign after checking the data on shop floor.
[][]Data entries should be recorded, signed and dated immediately after the completion of each activity, as applicable.
Correction of Recording Error / Overwriting or Incorrect Entry:
[][]In case of any wrong entry, do not over write or block the entry to make it obscure or unreadable. Strike out the wrong entry with straight single line passing through incorrect entry in [][]such a way that it remains readable.
[][]Make correct entry nearby it.
[][]For major changes annotate the actual reason for the correction or change, as the case may be.
[][]The correcting person shall put the initials along with date on which correction was done.
[][]Suppose ‘Cleaned’ is recorded in place of ‘Ensured’ by mistake on 10/01/XX and observed later during BMR review on 18/01/XX, it can be corrected at later date in the following way:
[][]Correct way for Correction on 18/01/XX:
[][]Initial Cleaned Ensured
[][]Date
[][]If space is not sufficient for correction, strike out the wrong entry with single line and highlight the same with an asterisk (*) nearby it. Define the asterisk at the bottom of the page and [][]Correct the wrong entry with initial and date.
[][]Entry of Missed Step:
[][]Entry of any missed step can be done later only if it can be proved that the step had been performed but the doer/performer and/or checker failed to document the same.
[][]The person making entry of missed step shall put the initials along with the date on which entry is done nearby entry of missed step.
[][]Working with Blank or Unused page/space :
[][]Do not leave blank space in any GMP record.
[][]Strike out any blank space or page with cross line and write in between the line N/A.
[][]Put initial and date at the end of the line, e.g., for following unused space strike out as specified :
Rounding – off of values:
[][]The rounding off values is applicable only to the calculations and not to the observed readings. Limits which are fixed numbers shall not be rounded off.
[][]e.g., If limit is 2 – 8 °C, then observed value 8.2 cannot be rounded off. Any value or figure which displayed by any equipment/instrument shall not be rounded off, e.g. if pH meter displayed is 3.79 than it should be mentioned as such and should not be rounded off to 3.8.
[][]When rounding off of any value is required, follow the below procedure.
[][]If last digit is equals to or greater than 5, it is eliminated and the preceding digit is increased by one.
[][]If last digit is smaller than 5, it is eliminated and the preceding digit remains unchanged.
[][]For examples see the below Illustration:
[][]Illustration of Rounding of Numerical Values for comparison with Requirements
[][]Requirements: Product Yield Limit (99.0% to 101.0%)
Unrounded Value to Rounded Value
[][] 98.926 shall be 98.93
[][] 100.124 shall be 100.12
[][] 99.655 shall be 99.66
Assigning Due Date:
[][]For assigning Due Date in all GMP records, calculate due date as per frequency for that particular activity from the day on which that activity is performed.
[][]Status of the activity can be valid up to the due date.
[][]For example, consider the case of assigning due date for re-cleaning of pre-filter for which cleaning frequency is 15 days.
[][]Suppose cleaning of pre-filter is done on 02/01/XX, since frequency of pre-filter is 15 days, due date for re-cleaning of pre-filter can be assigned 16/01/XX and cleaning can be considered valid up to 16/01/XX.
[][]Record all information in legible handwriting in all GMP records.
[][]Printouts from the instruments relevant to the analysis shall be retained and no such document shall be discarded even if they are not of use in the calculation.
Additional Documentation Practices for Quality Control Laboratory:
[][]Entries like “Complies/Does not comply” only allowed for the binary observations but the binary observation shall be specific.
[][]E.g. Limit test shall mention the observation noticed and TLC shall mention the comparison with the spot.
[][]Calculations shall be documented and rounding off shall be done as per SOP.
[][]Concordance of another analyst shall be taken for observations of subjective tests. E.g. limit tests, TLC plates etc. Both the analyst shall initialize and sign the observation.
[][]Printouts from the instruments relevant to the analysis shall be retained and no such document shall be discarded even if they are not of use in the calculation.
Annexure: Good Documentation Practice
N/A