Good Documentation Practices (GDP)

A set of guidelines known as “good documentation practices” (GDP) guarantees the accuracy, completeness, and reliability of records, papers, and information. These procedures are necessary for regulated sectors, such as the production of medical devices, where documentation plays a crucial role in the process of developing new products.

The following are some of the GDP principles:

• Document Control: All documents must be controlled to ensure that the most recent version is always available, and that obsolete or incorrect documents will be stored differently.
• Standardization: While preparing a document, always follow the standard format, which includes the use of clear language, correct grammar, and formatting guidelines.
• Review and Approval: All documents must be reviewed and approved by authorized personnel before issuance.
• Traceability: All changes made to a document must be recorded, along with the reason for the change, and the person responsible for making the change.
• Retention: All documents must be archived according to their retention requirements.

Some of the related documents in GDP include:

• Standard Operating Procedures (SOPs): SOPs are thorough, written instructions that outline the procedures to be followed for a certain task or procedure. Standard operating procedures (SOPs) are vital records for regulated businesses because they guarantee high-quality, consistent performance of all tasks.
• Batch Manufacturing Records: Documents that track a product’s manufacturing process are called batch records. They provide details about the raw materials utilized, the procedures followed during manufacturing, and the outcomes of the tests. In regulated sectors, batch records are crucial because they offer a comprehensive account of the production procedure for every product batch.
• Change Control Forms: Any modifications done in a record, procedure, or process are recorded using change control forms. They contain details like the approving signatures, the consequence of the modification, and the rationale for it.
• Training Records: Documents containing information about an employee’s training are called training records. They contain details such as the trainer’s name, the training subject, and the date of the session. In regulated businesses, training records are crucial because they guarantee that workers are properly and safely trained to carry out their job tasks.

ALCOA

GDP plays a vital role in guaranteeing the accuracy, completeness, and reliability of papers, records, and information. In regulated businesses, records like SOPs, production documents, control change forms, and training documents are crucial because they guarantee that goods are produced to strict specifications and adhere to legal standards.

• Attributable: Data shall be demonstrated who recorded and observed it, and when it was recorded and observed. There must be a signed date of the doer to note who wrote it and when.
• Legible: Data shall be easy to understand as well as recorded for a lifetime, original entries should be preserved and properly corrected.
• Contemporaneous: Data shall be recorded at the same time when the process is performed and recorded with the time and date.
• Original: Data shall be easy to access and maintained in its unaltered state or its original format.
• Accurate: Data should not contain any form errors and conform to the procedure described by the Organization.

Signature

It is necessary to maintain strict control over the use of your signature and initials of your name.

Each document should have the signature of the person who is doing verification and approving the document. The signature should be constant for each document, always document the specimen signature with the name of the respective person to avoid confusion.

The signature are most important tool for the identification of any authority instead of a name or the initials of a name.

If we found the signatures are not legible in this case we should use the initials.

Handwritten entries

Every action should be accompanied by the creation or completion of records, which should be done in a way that allows for the traceability of all major actions related to the production of pharmaceuticals.

Any changes made to an entry on a document must be dated and signed, and they must allow the original information to be read.

When applicable, a note of the modification’s purpose should be made.

Don’t use a whitener pen, scribble over the data, or scrawl over the original entry.

Copy of documents

The following document control must be included in all copies of the document:

“Master Copy” The first copy of the document.

“Controlled Copy” refers to a document copy that is stamped and signed by a competent individual, derived from an original copy and utilized in a controlled environment.

“Uncontrolled copy” A document copy created just for informational reasons from a master copy.

“Superseded copy” refers to a document that has been changed and replaced with an earlier version.

“Obsolete Copy” refers to a version of the document that should be retired.

Typical elements of a documentation system

• Document Numbering: All the documents will contain a unique identification code. This is specially issued as per the procedure for document control and by the quality assurance person.

Ex. The formats for QMS are numbered as follows:

Document No.: F.MNG.XX
Here,
F = Format
MNG = Management (Using the initials of departments)
XX = Number of the format

• Document effective date: Date of first document, date of modification, or date on which the document goes live. Every modification to the document will result in a new effective date, which is documented in the revision or amendment history.
• Document review date: The date that appears on the document following review by the head of the relevant department after consulting with the real user. Following approval, the day of review and the subsequent review date need to be noted, and all master and controlled copy are stamped as “reviewed.”
• Document Review: Review factors and criteria are as follows:
  • Always follow the standard
  • Traceability and consistency
  • Readability, comprehensibility, general understandability
  • Adequacy and feasibility of the approach
  • Extend of completeness
  • Testability of requirement
  • Use of specific requirements
  • Appropriate level of details
• Document Revision: There will be two types of revision:
  • Regular revision
    • At the end of the review period, the document will be reviewed and if any changes are required the document will be revised.
    • If during review it is determined that no changes are required, it is communicated internally that there is no revision to a particular document.
  • Technical revision
    • This type of revision is carried out when a gap is identified within the document. This revision shall be done by doing document change control and shall be recorded.