Good DocumentationBY KIMBERLY BONILLA, REGINA NGAN, NICHOLAS MARTIN, AND MOLLY ANGELL

Exercise

● Students will participate in an exercise which will enable them to understand reasons as to why so many Good Documentation Errors occur between the two highest trended departments during the Manufacturing Process.

● During the exercise the students will have an understanding of how it can be difficult to follow the Good Documentation Practices (GDP) of the Standard Operating Procedure (SOP) of our pharmaceutical company when they do not have the document readily available for them to perform their task.

Company Procedure

• We must always document our work PROMPTLY and ACCURATELY.• Entries shall be clear and legible using permanent ink that can be photocopied, read and

understood. • Enter the correct information, then initial and date. Place a circled number 1 in the

general area of the correction. Then place the matching number at a convenient location on the page.

• NEVER LEAVE BLANK LINES• Write “N/A” when not applicable (don’t leave blanks)• NO “WRITE OVERS”… single line through the mistake, correction, initial, date, add

matching ref # on the same page with explanation, initial and date that as well.Remember to ALWAYS use a circled number, then a matching (referenced) number at bottom

of page (or open area on document) with an explanation, initial and date it.

Flowchart

Repercussions

●3 Good Documentation Errors leads to a warning●The next Good Documentation Error, the employee is required to sit

with the Vice President of the company and get a write up ●The company is required under regulation by the FDA to follow

Good Documentation Practices. The FDA comes to the company to check the batch records

●Warning → Fine → Shutdown (The company will not be able to operate.)

Pareto Chart

Sterilization Checklist

❑ Batch Record Folder ❑ NO Write overs -→correct documentation errors as per procedure❑ Missing data❑ Signing batch records

❑With a Pen❑Initial of employee❑Dating in proper format in accordance with (Standard Operation

Procedure) SOP

Company Procedure for Entry Errors

A correction to an entry shall be initialed and dated by the originator or supervisor on the date the correction is made as follows:

❑ Draw a single line through the entire indistinct/incorrect number, date or word leaving the original entry legible.

❑ Enter the correct information then initial and date. Place a circled number 1 in the general area of the correction. Then place the matching number at a convenient location on the page (at the bottom of the page if space allows), and a brief explanation (e.g., “transposition error,” “ spelling error,” “calculation error,” “entry error.” etc) initial and date.

❑ When a correction is made on a later date, indicate the source or document used to verify the correction information, then initial and date.

NOTE: If more than one correction is made to the same page, the next correction will be followed by the next consecutive number.

Company Procedure for Missing Data

Missing data, signature or initials shall be completed by the originator or supervisor if for some reason a person is not able to sign a record, the supervisor shall sign/date the record for that person (“for/person”) and provide an explanation using the current date as follows:

❑ Place an asterisk (*) at the location of the missing information.

❑ Verify the accuracy before writing in the missing information.

❑ Write “entered on” and initial and date near the lat entry

❑ Place a matching asterisk at a convenient location on the page; indicate the source or the document used to verify the late entry, then initial and date.

NOTE:If more than one date, signature or initial is missing on the same page, the entry will be followed by either 2 asterisks or an asterisk with a circle around it. Place the matching asterisks at a convenient location on the page, indicate the source or document used to verify the late entry, then initial and date.

WHAT WE THINK SHOULD HAPPEN…

● CUT OUT ALL THE CONFUSION IN THE MIDDLE 2 stages: Stage 1 - Filling and Autoclave ONLY

Stage 2 - Inspection, Packaging and Shipping

When the employees have their batches readily accessible and in the one area, the production process will be much simpler and will decrease the occurence of documentation error!