Good Documentation Guidelines

Good documentation practice is an important part of the documentation in pharmaceuticals. It helps to improve the documentation quality of the company.

Good Documentation Practices should have the accompanying guideline:

● All sections, aside from IPQA, ought to be made with blue ball pen in clear and decipherable penmanship.

● All sections by IPQA might be done in black pen.

● Use of ink pens, gel pens, white out, cutting edge, erasers, air pens and pencils should be entirely maintained a strategic distance from.

● Sections might be done in clear, obvious and neat composition.

● Short terms should be maintained a strategic distance from to the most extreme degree if not separate truncations portraying the short structures might be given toward the finish of the archive.

● Information recording might be done online as the work is performed.

● The individual executed might sign alongside date in pertinent records.

● On the off chance that adjustment is to be done in any of the records at that point hit with single line in such a way, to the point that the first information must stay clear, obvious and intelligible and no data ought to be clouded by any methods.

● For good documentation practices, the right information is to be composed beside (wherever the reasonable space will be accessible), above or underneath and off base the information alongside initials, date and a concise clarification of the purpose behind the change.

● For composing purpose behind the rectification following shortened forms might be utilized for the different kind of slip-ups e.g. TY: For typographical mistake, TE: For exchange blunder, CE: For count mistake and SUP: For Supplementation, as illustration demonstrated as follows:

● Overwriting in archive might be entirely denied.

● Wherever more than one choice is accessible, tick (√) the choices which are appropriate.

● Wherever issued archive requires the passage of extra information, data which is not given in the record, the same ought to be manually written clearly and ought to be marked with date by the work force making the passage.

● Supplements or some other printout appended to records ought to be marked with date.

● On the off chance that any section of the archive does not require a passage, say “NA” (Not Applicable) or a line corner to corner over the page from left top to right base, put “NA” with a mark and date at the base.

● On the off chance that a procedure is not performed or is not appropriate in a page, Empty fields must be refuted by intersection them out, it ought to be shown by expressing “NA” (Not Applicable ) and inclining line over the page, with a mark and date at the base.

● In the event that a perception/recording is discovered OK/satisfactory, the same ought to be demonstrated with a tick check. Wherever legends are utilized, the same ought to be specied at the base of the report.

● Reason/Remark ought to be entered in the record for any signicant cancelations.

● In the event that any perceptions/signature/date to be rehashed, the same ought to be revised. Same ( — — “ — — ) checking ought not be utilized.

● For every movement, signature for operation done by and checked by ought to be finished.

● Where logbooks are utilized as a part of place of free organizations for recording, each page of the logbook ought to be numbered.

● Date might be composed in the frame either DD/MM/YY or DD/MM/YYYY, Where DD speaks to date, MM speaks to month; MMM speaks to first three letters in order of month and YY speaks to last two digits of the year or YYYY speak to the year 2016. For illustration 15/08/16 or 15/08/2016. Time passages should be composed as 24:00 hrs.

● Archive sections ought to be finished by the mindful individual for that operation.

● Report passages made utilizing carbon ought to be intelligible and clear.

● Try not to reuse scrap paper or sheets for recording any information.

● Note to build the space for recording without irritating the current strategy or substance.

● This note might be encased with Master SOP and duplicate of note might be encased with recording position by client division.

● On the off chance that any record/page must be change because of neatness, wrong passage reason, it might be reissued as “Copy” and the unique page might be held alongside it in the first record with take note of that this archive has “copy page”.