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Standard operating procedure in pharmaceutical industries rashmi nasare
1. STANDARD OPERATING PROCEDURE IN PHARMACEUTICAL INDUSTRIES
PRESENTED BY
MS. RASHMI NASARE
M. PHARM 1ND YR
UNDER THE SUPERVISION OF
DR. SHEELPRIYA WALDE
PROFESSOR
M. PHARM , PH.D., MBA
2. CONTENTS
1. STANDARD OPERATING PROCEDURE
- Introduction
- Aim
- Objectives
- Benefits
- Type of SOP
- SOP writing style
- DO’s
- Don’ts
- SOP Content
- SOP Process
2.MASTER BATCH RECORD
3.BATCH MANUFACTURING RECORD
3. INTRODUCTION
SOP – AIM FOR QUALITY
Standard Operating Procedure is a set of step by step written instructions intended to
document how to perform a routine activity.
BACK BONE of pharmaceutical industry.
Integral part of QUALITY ASSURANCE (QA).
Provides details of appropriate quality, cost & time constraints.
4. AIMS OF THE SOP
• Create the culture where quality objectives are transparent & well understand.
• To achieve quality output
• To achieve uniformity of performance
• To achieve uniformity of quality
5. OBJECTIVES
• To maintain the quality control & quality assurance.
• To serve as a training document for teaching users about the process for which
the SOP was written.
• To facilitate consistent conformance to quality system requirements & to support
data quality.
• To provide guidelines for accurate & timely data collection.
• Reduce miscommunication & failure to comply with industry regulation.
• To carry out operations correctively & always in same manner.
6. BENEFITS
• Provides information to perform job properly.
• To provide people with all safety, health, environmental & operational
information necessary to perform the job properly.
• Serves as a training document for users.
• Minimizes variation & promotes quality. Steps can be reviewed in accident
variations.
• Also provide, consistency (very important).
• Useful tool for training new members of staff.
• SOP assist to ensure that GMP is followed & achieved at all times.
• SOP’s help to assure the quality & consistency of the services, & thus minimize
harm to the patient.
7. TYPES OF SOP
• Analytical method
• Preparation of reagent
• Quality Assurance
• For operating instruments, equipment & apparatus
• Safety & Precautions
• Methodic
• Receiving & registration of sample
• Fundamental SOP
• To deal with complaints
8. SOP WRITING STYLE
• SOP’s shall be written in a concise, step by step, easy to read follow format.
• Information should not be complicated. The active voice, & present verb tense
should be used.
• Should be simple & short.
• Routine procedure that are short & require few decisions can be written using
simple steps formed.
• Long procedure consisting of more than 10 steps, should be written along with
graphical format or hierarchical steps.
• Procedure that require many decisions should be written along with flowchart.
9. DO’s
• Write in present tense. don’t use past tense, condition of future tense unless
you have good reason to do so.
• Avoid ambiguity & be concise.
• Reduce the word count where possible without changing the meaning of the
text.
• Keep the words short & get to point.
• Highlights exceptions. Use a symbol to flag that this is an exceptions & how to
handle it.
• Highlight warnings & use a longer or a warning icon.
DON’Ts
• Introduce acronyms without explaining what it means.
• Don’t use the word “may”, “ if possible” as it implies that the user can do
10. CONTENT OF SOP
• Company name & pagination
• Title
• Identification
• Review & Approval
• Purpose
• Scope
• Responsibility
• Procedure
SOP PROCESS
• SOP Preparation
• SOP Review & Approval
• Frequency of revisions & reviews
• Implementing SOP
• Management of SOP
11. MASTER BATCH RECORD
Master batch record, also known as Master Production Records.
They are version-controlled templates for your manufacturing process.
Dietary supplements manufacturing facilities are required to create these documents
& keep them on file, but what exactly is the FDA looking for in a Master Batch
Record.
Master batch record is a master document for any pharmaceutical product.
Master batch record contains all information about the manufacturing process for the
product.
Master batch is prepared by the research & development team of the company.
MBR is used as reference standard for preparing batch manufacturing record by
manufacturing units.
MBR is also called master manufacturing record, master production record.
12. MASTER BATCH RECORD Should include-
Product details:-
o Name, logo & address of the manufacturing company.
o Dosage form name.
o Brand name.
o Generic name.
o Product code
o Label claim of all ingredients
o Product description
o Batch size
o Pack size & packing style
o Manufacturing process
13. o Shelf life
o Storage condition
o MBR number & date
o Supersede MBR number & date
o Effective batch number
o Authorization by the production & quality assurance
o Head
o Flowchart
o Equipment
o Special instructions
o Calculation
o Packing process
o Yield
14. BATCH MANUFACTURING RECORD
• Batch manufacturing record (BMR) here “BMR” stands for batch manufacturing
record.
• This is one type of document which is produce & batch specific document which
gives entire picture of manufacturing history of each batch of every product.
• The “batch manufacturing record” is the necessary quality & GMP documentation
for tracing the complete cycle of manufacturing batch or lot.
• The batch manufacturing record should be checked before issuance to assure
that it is the correct & a legible accurate reproduction of the appropriate master
production instruction.
15. BATCH MANUFACTURING RECORD INCLUDES FOLLOWING THINGS
WHICH IS BASED ON MASTER FORMULA RECORD.
• Name of product
• Trade name
• Specification of raw material
• Name of raw material
• Specification of container, closure & packing material
• Name of items
• Weighment sheet
• Dispensing instruction
• List of equipment & machinery
• Packaging requirement
• Packaging instructions
• Precaution to be taken
• Finished product specification
• Expiry date
• Review due on.
