“Good documentation practice is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO.

For implementing efficient documentation practices, which meet, full GLP / GMP / ISO and FDA requirements.

Purpose of Documentations

  • Defines specifications and procedures for all materials and methods of manufacture and control
  • Ensures all personnel know what to do and when to do it
  • Ensure that authorized persons have all information necessary for release of product
  • Ensures documented evidence, traceability, provide records and audit trail for investigation
  • Ensures availability of data for validation, review and statistical analysis.

Classification of Documentation

Good documentation encompasses practically all the aspect of pharmaceutical production :

  • Building and premises: installation , validation , cleaning and maintenance
  • Personnel : Training, hygiene etc
  • Equipment : installation , calibration , validation , maintenance , cleaning
  • Materials: specification, testing, ware-housing, use, rejection/disposal.
  • Processing: individual steps in the process of manufacturing including controls thereof.
  • Finished goods: specifications, testing, storage, distribution, and rejection/disposal.
  • Complaints: investigation, actions, Return & Salvaged finished products.

Type of documents used in pharmaceuticals

Specifications: as per MHRA Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. We need specification for:

  1. Active and inactive materials
  2. Primary printed and packing materials
  3. Intermediate and semi-finished product
  4. Finished product

SOPs

it is a written, authorized functional instruction used as a reference by the person responsible for performance and are also used for training new operators in the performance of the procedure. 

Test method:

It is a written and approved documents describe the detailed testing procedure. 

List

Documents contain a catalog of any object such as list of equipment.

Certificates of Analysis:

it is an authentic documents shows the analytical reports and decision of acceptance/rejections

  • Label
  • Records
  • Organ gram
  • Job description
  • Batch Manufacturing records

BMR

It is an important document issued for every batch of product to assure, review and record keeping of any product batch.

There are following major content of BMR:
  1. Name of product, generic name, strength, shelf life, manufacturing date and exp date.
  2. A complete list of ingredients with full description, codes and quantity to be issued.
  3. A statement for theoretical yield and reconciliation.
  4. A complete MFG and control instructions, sampling and testing procedure, specification and precaution to be followed.
  5. A statement for processing location and equipment.
  6. The method or reference to method to be used for preparing the critical equipment including cleaning, assembling, calibrating and sterilizing.
  7. Dates and time of all activities
  8. Line clearance procedure in every steps
  9. Labeling control and specimen for coding in primary, secondary and tertiary packing materials
  10. Deviation record
  11. Result of examine made.