UNIT 4

CURRENT GOOD
DOCUMENTATION PRACTICES IN
BIOLOGICS MANUFACTURING
OBJECTIVES
• Explain the importance of current Good
Documentation Practices.

• Explain the application of current Good

Documentation Practices.

• Explain the types of documents that are specific

to biologics manufacturing.
INTRODUCTION

• Documentation, which is defined mostly as a

system of records, records, is essential to any
quality system.

• FDA's policy regarding documentation is, "if it

isn't written down, it wasn't done."

• If the documentation relating to a particular

batch of a regulated product (such as a drug) is
lost, accidentally destroyed, or is badly
prepared, then that batch of product cannot be
sold.
INTRODUCTION

• Such an error could cost the company

millions of dollars.

• Regulated companies, therefore, have

extensive systems in place to ensure the
work is recorded, that the documents
associated with every product are
completed.
INTRODUCTION

• That all documents are securely stored

and can be retrieved from storage, and
that documents are protected, just as is
the product itself.

• Documentation is equally important in a

research setting. If a researcher cannot
show written evidence of their results,
then those results are not credible.
 APPLICATION OF
DOCUMENTATION
• Documents have many important
functions.
• They provide a record of what was done,
by whom, when, how, and why.
• They provide objective evidence that a
product was made properly, that all
personnel followed proper procedures,
and that all equipment was operating
correctly.
 APPLICATION OF
DOCUMENTATION
Record what an individual has done
and observed.
Establish ownership for patent
purposes.
Tell workers how to perform a specific
task.
Establish the specifications by which
to evaluate a process or product.
 APPLICATION OF
DOCUMENTATION
Demonstrate that a procedure was
performed correctly.
Record operating parameters of a
laboratory instrument or a
manufacturing vessel.
Demonstrate by an evidence “trail”
that a product meets its requirements.
Ensure traceability.
 APPLICATION OF
DOCUMENTATION
Establish a contract between a
company and consumers. The written
specifications, labels and other
documents associated with a product
establish that contract.
Establish a contract between a
company and regulatory agencies.
DOCUMENTS THAT ARE
SPECIFIC TO PRODUCTION
FACILITIES
• Many types of documents found in
production facilities:

 Batch Records
 Regulatory Submission
 Release Of Final Product Records
BATCH RECORDS

• Accompany a particular batch of product.

• Directs the process by which a product is
to be made, the raw materials required,
and the sops to be followed.
• Stays with the product as it is made.
• Usually includes blanks to be filled in by
individual operators as procedures are
performed.
BATCH RECORDS

• Officially issued to the production crew

by the quality department. It is essential
that the batch record that is issued is
complete, readable, and correct.

• Some of the major components of a

batch record are listed as below:
 Product identification
 Document identification
BATCH RECORDS

 Company name
 Dates of manufacturing
 A step by step account of the processing and
testing to be done.
 The monitoring specifications – how will the
operators know if the process is proceeding
properly.
 Raw data that must be collected and blanks
to fill in to record it.
 Materials and equipment that will be used.
 Required signatures.
REGULATORY SUBMISSION
• Documents completed to meet the
requirements of an outside regulatory agency.
RELEASE OF FINAL PRODUCT
RECORDS
• Companies must complete product
release documents when a product has
been manufactured and tested.

• The release document certifies the

product, shows its specifications,
establishes that the product
documentation has been reviewed and
approved, and states that the product is
ready to be sold.