Good Documentation Practices

Contents:1. What is GDP?2. Purpose of GDP.3. Basic principles of GDP.4. Standards of GDP.5. Typical Elements of GDP.6. Some common errors.7. Benefits of GDP.

Why is GDP required?

Good documentation practices constitutes an important part of the Quality assurance system.

The PQS or QMS cannot be a success without a good documentation principle.

“If it isn’t written down, then it didn’t happen” TGA & FDA.

Basic principles of GDP

GDP is applicable to all GMP processes, SISPQ, the validated state of GMP product manufacture, facilities, equipment , computer systems and testing methods.

Some of the requirements are company specific and are soon to be implemented in your company.

a) Policy for good documentation practices.b) Green colored pen for QA dept & Blue pen for

Production dept and other depts (no other color to be used).

c) Uniform font type & size for all the documents.(currently we have for SOP only).

d) Centralized repository for all the documents.e) 1 min Retrieval of all the documents.f) Document review system.

WHY are document standards important??

Why are document standards important? In GMP environment documentation needs to meet

certain requirements to ensure product quality and product safety. If an instruction or record is poorly documented, then the manufacture or quality assurance /control of a product can be negatively impacted, potentially reducing patient safety.

The GMP regulations from PIC/S, FDA and EU all include mandatory sections on documentation.

Documentation provides both:a) Information on when, where, who, Why and how

the task was completed &b) Evidence proving that the tasks have been

completed as they should be.

WHY are document standards important??

Why are document standards important?Consequently, the standard of documentation In

the company can directly impact the level of success in manufacturing QUALITY products that are safe as well as contribute to a large extent in the success of an AUDIT.

A document is a valuable resource:It may be divided into two major sectionsDocuments –Procedural or instructional

documentation, and records evidence of compliance.

Ref- EU GMP chapter 4 further information on different types of documents some are enumerated in the next slide.

Different types of Documents:

Batch manufacturing records. Bill of Materials Specifications Policies Protocols Standard operating procedures (SOP) Manufacturing instructions Test Methods Checklists Forms & Log sheets and books. Training assessment Electronic and hardcopy Quality records. Certificate of Analysis Certificate of compliance Technical transfer reports Validation documents APQR

The general requirements of documentation.

Clearly written documentation.Using indelible ink.Legible hand written entries.Reviewing and approving.Signatures Signed delegation of responsibilities.Page numbering.

All documents must be written in a manner that prevents errors and ensures consistency. If documents are to be used together for e.g. An SOP and an Annexure should be a reference to each other. Ensure that there is traceability between two or more documents using documents numbers.

All records should be filled with indelible ink for long term legibility. Do not use pencil or ink that can be erased.

Never use WHITE ink or colored pencils or Crayons.

A document is unusable if it cannot be read.

Don’t use Don’t use

Care must be taken to ensure that handwriting is legible. All the entries must be made at the time the task is performed and should

be legibly signed and dated. The language should be clear and unambiguous. The signatures on the documents must be unique to the individual and

listed within the site signature register to ensure it is traceable. Staff are not permitted to sign for another member of the staff unless

delegated. Signatures must never be forged. In the event of a critical member of the staff is absent for a time, they

must delegate responsibility to another qualified Person proceduralised in a document. All the GMP documents need to be numbered From the start to the end.(Pagination) All the fields should have an entry, even if it is N/A. Alternatively multiple blank spaces/rows/columns on a record must be marked out with a single line across the whole field space. This ensures that the records cannot the added to at a later date

Without proper checking or approval Indicates that not completing a field/space is deliberate. Marking out a large space or whole page may be completed with

a diagonal line. Use N/A above the line and sign and date to show that the field

/space is not applicable. An explanation may be required why the space /field is not applicable.

Important: A GMP record is incomplete when the field/spaces for entries have not been filled. Do not discard a page of a record just because the fields are not applicable because the page could be mistaken as missing. Do not use ditto marks to indicate the field is the same as above.

Checking corrections: Amendments may be made after the contents of the record has already been checked.

Handling of Blank spaces:

Therefore , the corrections must be checked by the same person who checked the rest of the document.The checking analyst should: Review the change and ensure that it has been made in a compliant manner- Clear, legible, accurate, original entry is still visible etc. Review the change with respect to the content of the rest of the

document. Sign and date the corrections.Important: Correction dates occurring after the last date that the

record was checked are not compliant.

Recording of Numbers: Decimal numbers: In general if a decimal value is a fraction of one then a zero must be placed before the decimal point. E.g. Records 0.98 rather than .98. The number of decimal places to be recorded should be Outlined in a procedure. E.g. When a specification limit is 2.55 to 2.85 and the result is 2.7, then record the results as 2.70 and not 2.7.

Rounding: Rounding off of the values where ever applicable. Date format: dates following common practice with the country such as

day/month/year. Example: 06/03/2015 Time format: Record time in 24 hour format (00.00 to 23.59) or denoting AM or

PM example-: 1 PM or 13.00 hrs. Record a period of time in hours or minutes. The site GDP procedure should

indicate when to use 24 hour increments. E.g. 1 hr 36 min or 1:36 min or 96 min.

Dealing with attachments and printouts: Attachments to forms : attach one record to another (e.g. if a record is to be

attached to a form): Staple the attachment to the record; paper clips are not acceptable. Cross reference the record an the form with each other e.g. the record references

the report number and the report references the record number. Attachments to work books /log books: Secure the attachment to the appropriate

space of the workbook/logbook – use tape or staples, glue or paper clips are not acceptable.

Do not obscure any data on either the workbook page or attachment. Ensure sufficient identification on the attachment to ensure traceability in the event

it becomes separated (cross reference). Indicate on the original document that there is an attachment. Sign and date both the workbook and attachment. Thermal Printouts: all printouts made on thermal paper must be copied before

attaching to a report or filing. Indicate “copy of original” or “true copy” on the copy and the initial and date.

Do not tape over information on thermal paper as the tape will cause the data to rapidly fade. After making a copy, secure the original and the copy with the reports.

Handwritten Corrections: If a correction id to be made, the original record must still be legible: 1) make a single line through the error-never use correction fluid, multiple

cross-outs or marker pen to obscure the original record. 2) Record the correction close by-numbering corrections is acceptable when

space is limited. If the record becomes too congested with corrections, an attachment may be used , how ever the original record must indicate the number of pages attached and the attachment reference the record is related to.

3) Provide a brief comment why the change is required (as appropriate). 4) Initial the change so that it is clear that the correction is deliberate. 5) Record the date of the correction next to the initials so that there is a

record of when the change was made. Handling omitted data: If an entry was omitted and must be made at a time alter than the activity

was performed then : 1) Clearly indicate the date the activity was performed and the date the

activity is recorded on the documentation. 2) Document an expiration to substantiate the entry and the reason for the delay in

recording. 3) Sign and date the change. Important: Backdating entries is not permitted.

Communication Styles: 1) Using word that everyone can understand (reduce jargon or

abbreviations). 2)Using words with unambiguous meaning. 3) Using white space. 4) Providing enough detail to make sense of it in the future. 5) Using pictorial or graphical aids (including tables). 6) Previous experience and expectations. 7) Consistent wording to avoid confusion. 8) Consistent styled templates. 9) E mails should never be written in block letters (indicative of shouting at the recipient). 10) Avoid name calling on official e mails or internal mails. 11) While replying to all make sure it really needs to be sent to all.

Handwritten corrections in the Documents:

Suggestions for GDP: Print a document only when you are sure that the

document is correct and free of errors, so that we do not waste paper.

Do it right first time. As humans we all make errors so there is not need to hide

it, but instead the correct documentation practice should be followed.

Archival and easy retrieval of the documents is the key to success for an organization.

No documents should go out of the company. If at all it has to be sent then it should be with proper procedure and consent of the department heads.

Respect the Documents.

Improper documentation could lead to inappropriate and heavy monetary losses.

Are we ready for it.