standard operating procedure is the type of document which is used in reference copy for batch manufacturing record & master production records.

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.

16. REFERENCE
1) ISOP journal of pharmacy €-ISSN:-2250-3013,(P)-ISSN:2319-4219
www.isophr.org volume 5,issue 1 (January 2015),pp:-29-36
2) http://www.pharmainfo.net/reviews/SOP
3) http://www.werum.com
4) http://m.authorstream.com/presentation/gosaimadhuri-1561524-BMR
5) http://www.slideshare.net/mobile/simran4/SOP

17. THANK YOU