Good Documentation Practice

Principle

Batch Record

Mohammad Naiem Salem

 Why Good Documentation Practice is Important ?

To Ensure That :

• All personnel
concerned with
manufacture know
what to do and when
to do it;
• Authorized Persons have all
the information necessary
to decide whether or not to
release a batch of a
medicine for sale;
the existence of
documented evidence,
traceability, and to
provide records and an
audit trail that will
permit investigation.

It ensures the availability

of the data needed for
validation, review and
statistical analysis.
 Good Documentation Practice Principle

Essential part of the quality for all aspects of GMP

assurance system

• Its aims are to define the specifications and procedures for all
materials and methods of manufacture and control

The design and use of documents depend upon the manufacturer.

electronic data processing In some cases some or all of

systems or by photographic or the documents described may
other reliable means. be brought together,
but they will usually be
separate.
 • Master Record:
A document or set of documents that
serve as a basis for the batch
documentation (blank batch record).

• Master Formula:
• A document or set of documents
specifying the starting materials with
their quantities and the packaging
materials,
• together with a description of the
A formally authorized master
procedures and precautions required
formula should exist for each
to produce a specified quantity of a
product and batch size to be
finished product
manufactured
• as well as the processing
instructions, including the in-process
controls.
 Pre execution

• - Review the master batch record (MBR) or master formula record (MFR) for
the product and batch size. ??
• The MBR contains the instructions, recipe or formula, and specific
manufacturing process for a particular product².
• Verify that all the raw materials, equipment, packaging materials and
personnel are available and meet the specifications and requirements of the
MBR¹³.
• Perform any necessary calibration, cleaning, sanitization or maintenance of
the equipment and facilities¹³.
• Label all the materials and equipment with batch number, product name,
expiry date and other relevant information¹³.Prepare any necessary solutions,
reagents or media acc to MBR
 During the Manufacturing
• - Follow the work instructions for each station or stage of production as specified in the
MBR¹².
• Record the start and end time, operator name, equipment used, material lot number,
• process parameters, yield and any deviations or incidents¹³.
• Perform any necessary sampling, testing or quality control procedures as specified in the
MBR¹².
• Record the test results, acceptance criteria and any deviations or incidents¹³.
• Document any in-process adjustments or corrections made to the process or product
according to the MBR¹³.
• Transfer the product to the next station or stage of production or to the storage area
according to the MBR¹³.
 After completing the batch

• - Perform any necessary cleaning, sanitization or maintenance of the equipment and

facilities used in the batch¹³.
• - Verify that all the records are complete, accurate and consistent with the MBR¹³.
• Review and approve the batch record by authorized personnel¹³.
• Store the batch record in a secure location according to the regulatory requirements¹³.
 Some important steps to highlight are:

• Verifying that all the materials, equipment and personnel meet the specifications and
requirements of the MBR before starting the batch.
• Following the work instructions and quality procedures exactly as specified in the
MBR during the batch.
• Documenting every step of the process and recording any deviations or incidents
that occur during the batch.
• Reviewing and approving the batch record by authorized personnel after completing
the batch.