Are You Practicing GDPs?

© E.M.M.A. INTERNATIONAL GROUP, INC. 1

Are You Practicing GDPs?

Good Documentation Practices

E.M.M.A. INTERNATIONAL CONSULTING GROUP

JULY 2015

http://www.emmainternational.com/

http://www.emmainternational.com/


GDPs• Good Documentation Practices = GDPs

• Essential for working in FDA-regulated industries

• Utilize GDPs in the generation, review, approval and execution of controlled documents, such as• Procedures• Protocols• Records• Reports

This quick guide can teach and remind you how to use GDPs in your everyday documentation work


Document Formatting• Official company name, ‘Confidential’ & trademark• Legal department can guide you on requirements to protect your company on

internal and external documents

• Number all pages• x of y

• Headings, tables, graphs, etc. require clear & concise titles

• For larger & more complicated documents, include a contents page


Document Formatting (cont’d) • Record version numbers on documents

• Approval date and effective date where appropriate• Eliminate doubt of when document was official & requirements required to be followed

• Provide signatures of issuance/approval


Document Formatting (cont’d) Company

Name

# of Pages

Effective Date

Clear Title

Document & Revision #’s


Blank Spaces• All spaces must have

data/information or ‘N/A’ (not applicable)

• Blank pages must have a single diagonal line with ‘N/A’ with initials and date


Abbreviations• First Use: Write full text spelling with abbreviation in brackets

• Subsequent Uses: Write abbreviation


Legible & Permanent Entries• Data must be recorded• Directly• Promptly• Legibly

• Ensure all hand-written entries are legible and photocopy clearly

• Verify someone other than the originator can read every letter and number

• Do NOT use pencils or erasable pen inks


Signing, Initializing, & Dating• Sign or initial, and date all entries at the time they are made• Form/procedure must indicate if full signature is required

• Ensure all data entries are• Dated on the date of entry• Signed/initialed by person entering the data

• NEVER sign anyone else’s name• Falsification

• Do not post- or pre-date

• Use company defined date format to eliminate ambiguity


Documenting• All entries must be on controlled documents

• Do NOT use• Scrap paper• Post-it ® notes• Uncontrolled sheets

• Calculations must be approved by a second person for accuracy and completeness

• Ditto marks/arrows are unacceptable in place of information/data


Corrections: Data Entry• Draw a straight line through error• Must not erase or obscure original data/information

• Enter correct data/information adjacent to the correction

• Provide explanation for the change

• Do not use white out, tape, or erasers

• Initial and date corrections at the time they are made

No: Yes:


Corrections: Data Entry• Short-hand notation for explaining corrections

Short-Hand Correction Explanation

CE Calculation Error

DE Dosing Error

LE Late Entry

MI Malfunctioning Instrument

RE Recording Error

SE Spelling Error

TE Technical Error

TRE Transcription Error

WD Wrong Date


Corrections: Approved Documents• Require re-approval to ensure correction is• Appropriate• Accurate• Correct in the context of the document as whole

• The same level of management that approved the original document should approve the correction

• Refer to corporate police for procedure for requesting, implementing, and approving document corrections


Raw Data• Includes: laboratory worksheets, records, memoranda, or notes, that are the

results of original observations

• Must not be destroyed

• Should be sufficiently detailed to allow reconstruction of the control record or report

• Reconstruction must be capable of reproducible results and conclusions


Data/Information Entry Fields• Ensure all entry fields are completed

• Enter ‘N/A’ in fields not requiring entries

• Draw a single line across unused portion of page where no data/information is required• Enter ‘N/A’ or an explanation with initials & date


Attaching Documents• Securely fasten attachments and/or raw data pages together

• Attachments and forms must contain the unique document identifier or reference

• Use permanent tape to attach pages, sheets, and forms to laboratory notebooks• Initial & date along the edge of the attachment and the underlying page

• Reference any forms by the form number


Data/Information Review & Approval

Refer to the appropriate Standard Operating Procedure(s) (SOP) to ensure all data/information is correctly• Reviewed/approved• Signed/dated


Document Storage• Current documents should be readily available for daily use• Electronic or hard copy

• Retired documents should be archived and kept under restricted access


Practice Makes Perfect• Keep this presentation handy as a quick reference to ensure you are following

GDPs

• Putting these GDPs into practice is a simple way to help your organization avoid receiving Form 483s and warning letters from the FDA

• Remember, in the eyes of the FDA, “If it isn’t documented, it didn’t happen.”


Reference• enKap. FDA Compliance Digest. Available from: http://

enkap.org/docs/good_doc_practice_guide.pdf

http://enkap.org/docs/good_doc_practice_guide.pdf



Healthcare

Are You Practicing GDPs?