GOOD DOCUMENTATION PRACTICES - Analytical Lab Group · GOOD DOCUMENAION PACICES 1285 Corporate Center Dr, Ste 110, Eagan, MN 55121, USA [email protected] AnalyticalLabGroup.com

GLP | GMP | ISO/IEC17025:2017 accredited | ISO 9001 compliant | FDA registered | DEA registered

GOOD DOCUMENTATION PRACTICES

WHITE PAPER


1285 Corporate Center Dr, Ste 110, Eagan, MN 55121, USA [email protected] AnalyticalLabGroup.com (877) 287-8378

HELPING PROTECT LIFE™

Good documentation practices (GDP) are a necessity when working within a current good manufacturing practices environment. This white paper by Analytical Lab Group reviews the importance of following GDP when documenting data and information within a cGMP environment.

GDP OVERVIEWGood documentation practices are a clearly defined method for documenting data and records within a cGMP business environment. GDP should be used on any GMP document or logbook. Companies should have an SOP or policy that defines all the specific requirements for documenting within that company. It is important to use GDP to ensure industry standards are being met. Good documentation practices to define include:

+ Ink color

+ Abbreviations• EE = Entry Error• WD = Wrong Date• NA = Not Applicable

+ Date formats

+ Types of logbooks / binders / forms that can be used

GENERAL REQUIREMENTSCLEARLY WRITTEN DOCUMENTATIONAll data entries must be accurately recorded in a manner consistent with the governing procedure or policy in order to prevent errors. Everything should be documented — if it is not written down according to procedure, it will be assumed that it didn't happen.

AMENDING DATAAny corrections made to existing data or documentation must be done clearly in accordance with the procedure. When correcting, data should never be covered up or destroyed in the process. A single line through the incorrect data with an explanation, initials and date is how it should be done.




USE INDELIBLE INKcGMP records need to be permanent and last indefinitely. Therefore, pencil or erasable ink should not be used. The acceptable color of ink should be defined by the governing procedure — this is typically blue or black ink. This also helps provide consistency throughout the documentation within the business.

REVIEWING AND APPROVINGAll cGMP documents should be reviewed by a properly trained individual who did not perform the actual task to ensure there are no errors. A signature and date of the reviewer/approver signifies that the data has been reviewed and is complete and accurate.

PAGE NUMBERINGAll cGMP pages or forms should be numbered "Page number X of Y" to indicate total number of pages within the document.

HANDWRITTEN DOCUMENTATIONAll handwritten entries need to be recorded as neatly as possible so the entry is legible for future reference. All entries must be made at the time the task is performed, initialed and dated. Remember never to sign for other individuals.

EXAMPLES OF DOCUMENTATIONCORRECT WAYS TO NA BLANK SPACES




INCORRECT WAYS TO NA BLANK SPACES

MAKING CORRECTIONS TO A DATE, NUMBER OR WORDENTIRE DATE, NUMBER OR WORD NEEDS TO BE CROSSED OUT, THEN FIXED




CORRECTIONS IN SMALL SPACES

SOME COMMON GDP ERRORS TO AVOID

+ Write overs

+ Illegible entry

+ Ditto marks " "

+ Drawing a line with an arrow down a row of spaces to indicate "the same thing should be written there"

+ Complete cover up of or scribble over any data when crossing out. Always use one line cross-outs only.

ABOUT ANALYTICAL LAB GROUPALG is an industry leader in the specialty contract lab space and comprises FDA- and EPA-focused laboratories across the United States, with facilities in San Francisco, Minneapolis and Boston. Our ALG team is focused on Helping Protect Life™ through infection prevention, with the most comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotech and healthcare spaces. Our facilities are GLP/GMP compliant, FDA registered, DEA licensed, ISO/IEC 17025:2017 accredited and A2LA accredited #3383.01 & 3383.02.

Our client-focused scientific, quality assurance, technical staff has built an unparalled reputation for technical expertise, regulatory compliance knowledge, and superior client service.

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GOOD DOCUMENTATION PRACTICES - Analytical Lab Group · GOOD DOCUMENAION PACICES 1285 Corporate Center Dr, Ste 110, Eagan, MN 55121, USA [email protected] AnalyticalLabGroup.com