This document discusses standard operating procedures, documentation, and record keeping in the pharmaceutical industry. It defines key terms like standard operating procedure, documentation, and different types of records. It explains the importance of SOPs and documentation in ensuring uniformity, quality control, and compliance. It also outlines the typical contents, types, and processes involved in SOPs, documentation and maintaining different records like batch records, quality control records, and distribution records.

1. STANDARD OPERATING
PROCEDURE, RECORDS AND GOOD
PRACTICE OF PRODUCTION
PRESENTED BY: SRASHTI MAHESHWARI
M.PHARM (PHARMACEUTICAL QUALITY
ASSURANCE)
1ST YEAR

2. DOCUMENT
A DOCUMENT is a piece of written, printed or
electronic matter that provides information or
serves as an official record.

3. DOCUMENTATION
Documentation is the cornerstone of any company’s
quality management system and is an essential GMP
requirement.
Documentation defines a system of information and
control so that risks assessment in misinterpretation
and error in oral communication are minimized.
YOUR DOCUMENTATION IS AN
ADVERTISEMENT FOR YOUR
WORK.

6. STANDARD OPERATING
PROCEDURE
Standard Operating Procedure (SOP) is a set of
step by step directions or instructions intended to
document how to perform a routine activity.
It is back bone of pharmaceutical industry.
Integral part of quality assurance.
SOP provides details of appropriate quality, cost
and time limitation.

7. AIMS AND OBJECTIVES OF
SOP
To achieve quality output.
To achieve uniformity of performance.
To achieve uniformity of quality.
Reduce miscommunication and failure to comply
with industry regulation.
To provide guidelines for accurate and timely data
collection

9. PURPOSE OF SOP
Describe how to perform routine activities.
Provide training.
Guide and standardize working procedures
Ensure quality and integrity of data generatedinformation
captured.
Reconstructionsrepeatability.
Provide an auditing tool.

10. TYPES OF SOP
Analytical method
Preparation of reagent
For operating instruments, equipments
Safety and precautions
Receiving and registration of sample
Fundamental SOP
To deal with complaints

11. CONTENT OF SOP
Company’s name and pagination
Title
Identification
Review and approval
Purpose
Scope
Responsibility
Procedure

12. SOP WRITING STYLE
SOP’s shall be written in concise, step by step manner.
Information should not be complicated. The active voice and present
verb tense should be used.
Should be short and simple
Routine procedures that are short and require few decisions can be
written using simple steps format
Long procedures involve more than 10 steps and should be written
along with graphical format.
Procedures that require many decisions should be written along with
flowchart.

13. SOP PROCESS
SOP preparation
SOP review and approval
Frequency of revision and reviews
Implementing SOP
Management of SOP

16. SOP DEVELOPMENT

18. RECORDS
Records are used to show that the operations
are in compliance with GMP.
Records allow companies to trace all the
development, manufacturing and testing
activities to assess the quality operation in
the company.

19. TYPES OF RECORDS
Various kind of records maintained in the pharmaceutical
industry. Some are as follow:
Master formula record
Batch manufacturing records
Distribution records
Batch production records
Calibration records
Records for stability studies
Batch packaging records
Quality control records

20. MASTER FORMULA RECORDS (MFR)
Master formula record are
defined as written
procedures that give
complete description of all
aspects of manufacturing,
packaging and control with
intention to ensure the
purity, identity quality and
strength of product.
It should be prepared by
competent technical staff
and should be reviewed by
the heads of production and
quality control departments.

21. BATCH MANUFACTURING
RECORD(BMR)
Batch manufacturing record is a
written document from the batch that
is prepared during the
pharmaceutical manufacturing
process.
It contains actual data of the batch
manufacturing and whole
manufacturing process step by step.
All stages are includes in the batch
manufacturing record from the
distribution of the raw material to the
final packaging.
Batch manufacturing record is like a
proof that batches were properly
made and checked by quality control
personnel.

22. DISTRIBUTION RECORD
Distribution records are written document which contain data
related to distribution of drugs from manufacturer to distributors.
They should contain name and strength of the product and
description of the dosage form, name and address of the
consignee, data and quality shipped and lot or control number of
the drug product.
These records should be maintained in such a way that a batch
related distribution records is easily available.
Records for distribution shall be maintained in a manner such
that finished batch of a drug can be traced to the retain level to
facilitate prompt and complete recall of the batch, if and when
necessary.

23. Content of distribution
record
Product Information
Transaction information
Distribution information
Recipient information

24. BATCH PACKAGING
RECORD
Batch packaging record should be kept for
each batch or part of batch processed. It
should be based on the relevant parts of the
packaging instruction.
It approved by the person responsible for the
packaging operations.

25. QUALITY CONTROL RECORDS
Quality control records show :
Date of performance of test
Identification of material
Name of supplier
Date of receipt
Batch number
Quantity received
Quality of sample taken
Statement of result of test
Signature of person who performs the test

26. CALIBRATION RECORDS FOR
INSTRUMENTS
The procedure for calibration records must include the
following detail:
Name of the instrument
Date of calibration
Reference standards used
Other reagents or tools used
Name and sign of the person who calibrated

27. GOOD PRACTICE OF PRODUCTION
Production operations must follow clearly defined
procedures in accordance with manufacturing and
marketing authorisations, with the objective of
obtaining products of the requisite quality.
All handling of materials and products such as
receipt and cleaning, quarantine, sampling,
storage, labelling, dispensing, processing,
packaging and distribution should be done in
accordance with written procedures or instructions
and where necessary, recorded.