GOOD DOCUMENTATION PRACTICES (GDP)

(Dr.) Meenakshi Gupta

Senior Assistant Professor

University Institute of Pharmacy

C. S. J. M. University Kanpur U.P

What is Documentation?

• “Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use.”

• Documentation provides-

1. Information on when, where, who, why & How to Complete tasks

2. Evidence providing that the tasks have been completed as they should be.

OBJECTIVES OF DOCUMENTS

1.To define the specifications and procedures for all materials and method of manufactured and control.2.To ensure that all personal concern with manufacture know what to do and when to do it.3.To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale.4.To ensure the existence of documented evidence, trace ability, and to provide records and an audit trail that will permit investigation.5.It ensures the availability of the data needed for validation, review and statistical analysis.

Characteristics of Good Documents

• Have a clear title.

• Have an identification number.

• Be approved by authorized person.

• Have the date of issue

• Have a due date of revision.

• List to whom it has been issued.

For effective use of documents, they should be designed and prepared with utmost care

Each document shall:

• The instructions shall be precise and not ambiguous.

• They shall be for each individual step and not combined.E.g. Weigh the materials; charge the weighed materials into the blend

• Instructions shall be in imperative mood(direct command).

• Where entry of any data (e.g. temperature, weight) is expected to be made by the person using the document:i. Sufficient space shall be provided for making the entry.ii. Heading shall clearly indicate what is to be entered, and who is responsible.iii. All entries shall be in ink.iv. All entries shall be clear and legible.v. Person making the entries shall confirm the entry by initialing/signing the same.vi. An error in entry shall be so corrected that the original (wrong) entry is not lost. The reason for correction shall also be recorded, initialed and dated.

Characteristics of Good Documents

• Documentation system should provide for a periodic review, and revision, if necessary, of any document, or part thereof.

• Such revised versions shall also be approved by the authorized persons.

• Updated/revised versions shall also be superseding the previous edition, and the document shall clearly indicate this.

Characteristics of Good Documents

Why Documentation is essential?• To ensure Quality & Safety of the product in a GMP

Environment, documentation needs to meet certain requirements.

• If record is poorly documented, then the manufacturer or Quality assurance/control of a product can be negatively impacted, potentially reducing patient safety.

• the standards of documentation within a industry directly impact the level of success in manufacturing quality products that are safe as well as success during audit situations.

• Ensures documented evidence, traceability, provide records and audit trails for investigation

• Ensures availability of data for validation, review and statistical analysis. Control of Process - Ensures all staff knows what to do and when to do it. To improve performance

What are Common Documentation Errors?

• Missing signature and date at the time of activity performed.

• Write-overs, multiple line-through and use of "White-out" or other masking device.

• Wrong and non-uniform date and signature entry.

• Writing a note that the activity performed on one day and signed on another day.

• Document error correction not signed/dated, and didn’t include a reason for the correction.

• Illegible writing and too many corrections.

• The delegation for the batch release, in case of absence of the QA manager, not recorded / documented.

How are mistakes corrected?

• Draw a single line through the error

• Make the correction next to the error

• Write an explanation for the error

• Sign and date the correction.

A Famous Proverb says:

“IF YOU HAVE NOT DOCUMENTED AN

ACTIVITY, YOU HAVE NOT DONE

IT”.

What are the principles of Good Documentation Practice (GDP)

• GDP describes the standards by which documentation is created and maintained in the pharmaceutical industry

• Design of document must be correct, complete, current & traceable

• Must be Prepared, Reviewed and Proper Distribution

What constitute good Documentation?• Clearly Written documentation: All documents must be

accurate & written in a manner that prevents errors and ensure consistency.

• Using indelible ink: All records must be filled out in indelible(permanent) ink for long term legibility (readability). Don’t use pencil or ink that can be erased

• Legible (readable)hand written entries

• Reviewing & approving

• Staff Signatures: Hand written Signature must be unique to the individual and listed within the site signature register to ensure that signature is traceable to a member of staff. Staff are not permitted to sign for another member of staff unless delegated.

• The document must provide clear information that is understood by all customers

• Traceable: Who recorded it, where and why.

• The information should be documented at the correct time frame along with flow of events

• Must be long lasting and durable

• Accessible: Easily available for review.

What constitute good Documentation?

What are the different type of documentation?

Documentation may be divided into

1. Documents(procedural or instructional documentation )

2. Records(evidence of Compliance )

Different types of documents

• Batch records

• Specifications

• Validation & Qualification Records

• Calibration Records

• Standard procedure

• Room Temperature/ %RH Records

• Stability Study Summary Report

• Machine Logs

• Product and sample labels

• Analytical Methods

• Manufacturing Procedures

Some Guidance Documents

• Schedule M of Drug And Cosmetics Act 1940

• ISO - 9001 : 2008

• US FDA CFR sections

–21 CFR 11, 210 & 211

17

Schedule M

18

ISO – 9001 :2008

Section 4: Quality Management System

4.2.2 Control of Documents

4.2.3 Control of Records

19

Document

• An approved instruction either in paper or electronic form

which guides about how an activity shall be executed.

20

Record

• A record is often considered as document.

• Records provide evidence that activities have been

performed or results have been achieved.

• They always document the past.

• Provide background history

• Provide legally valid evidence

• Examples: Humidity and temperature control records, Calibration records, Emergency & maintenance records, Training records, BMRs(Batch Manufacturing Record), Log Books etc.

21

Document Vs Record

• A document can be a procedure, specification, drawing,

work instruction and the record is also a document with the

difference that it provides evidence of compliance with

established requirements and effectiveness of the operation

of QMS.

Some tips on GDP

•Records should be filled online.

•Superseded documents should be retained for a specific period of time

•Records should be retained for at least one year after the expiry date of the finished product.

• Concise, legible, accurate and traceable.

Type of Documents Minimum Retention Period

Batch related Records (Executed Documents &

Analytical Report- Chemical & Microbiology)

1 year beyond expiry date whichever is

longer.

Legal Documents (Mfg. Lic.,Regulatory Approvals,

Certificates)

for posterity

Master Documents and Supersedes and Obsolete Copy of Master document

SOP (Standard Operating Procedures) 5 years from the Obsolete Date

Standard Test Procedures (STP), 5 years from the Obsolete Date

Site Master File

Master Formula Card & QFR, BMR& BPR

For Posterity (Current version)

5 years from the obsolete Date

Stability Study Protocol & Reports For Posterity

Typical Retention Time

Questions

• Why Documentation is essential?

• What is Documentation?

• What are the principles of Good Documentation Practice (GDP)and what are the different type of documents used?

• What constitute good Documentation and what are common documentation errors?

• What are the benefits of Good Documentation Practice (GDP)?