standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.

1. Standard operating procedure in pharmaceutical industries
Presented by
Ms. Rashmi Nasare
M. Pharm 1nd yr
Under the supervision of
Dr. Sheelpriya Walde
Professor
1

2. contents
 Introduction
 Aim of SOP
 Objectives
 Benefit
 Purpose
 SOP writing style
 SOP format
 Do’s
 Don’ts
 General format for SOP
 SOP Process
 What kind of SOP needed?
 Types of SOP
 SOP Content
 SOP Development 2

3. Introduction
 Definition:-
Standard operating procedure is a step by
step procedure or directions as established by a
quality square industry involved in facility producing
,testing or research.
 A standard operating procedure does not required
or need Explaination or publication because it is
standard.
 SOP is the set of step by step written instructions
intended to document how to perform routinely.
 They are the back bone of pharmaceutical
industry. 3

4. Continued….
 They are the back bone of pharmaceutical industry.
 Integral part of QUALITY ASSURANCE (QA).
 Provides details of appropriate quality, cost & time
constraints.
 Standard operating is an also part of CGMP & GDP
(Good documentation practices).
4

5. 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

6. 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

7. benefits
 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.
 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

8. Purpose of sop
 Describe how to perform routine activities
 Provide & training aid
 Guide & standardize working procedures
 Ensure quality & integrity of data
generated/information captured
 Reconstructions/repeatability
 Provide an auditing tool
8

9. SOP writing style
 Write one SOP per study-related activity. Ex:-
Performance of lumbar puncture, handling,
transport & storage of CSF sample, microscopic
detection of trypanosomes etc… Do not mixed
too many activities in one SOP.
 Make sure you are familiar with the procedure to
be described in the SOP. If you are not, ask
somebody who performs the procedure regularly
to show it to you.
 Describe in detailed how the procedure is being
carried out
9

10.  List of the steps in chronological order as in the
example below
Making a cup of tea:-
1. collect a cup & saucer.
2. place teabag into cup
3. boil water in kettle
4. add water to cup & teabag
5. allow tea to infuse
6.remove teabag
7. add milk & sugar (if desired)
10

11.  Use a simple , active language eg:- ‘weigh 10 mg’
rather than ‘10 mg should be weighed’
 Include all necessary information to perform the
procedure, not more.
 Use the fewest possible word, if different steps
are involved in the activity, use bullet points
 If possible add visual displays (VD) such as
diagrams, flow charts, pictures or table
11

12.  Have a specific reader in mind. Know the type of
person who will be reading the procedure & tailor
the writing according to the end user.
 Avoid “do this or alternatively do that”
 Avoid “where appropriate”
 Make sure all technical terms & acronyms are
defined under the “definition” section
12

13. SOP format
 Each SOP format should have a unique identifier
which include:-
 The number of the work package under which the
SOP is being developed
 An acronym referring to the type of the procedure
(LAB; for laboratory SOP, DOC; for SOP related to
documentation management, CLIN; for clinical
SOP, DATA ; for SOP related to data management,
QUAL; for SOP related to Quality assurance (QA) &
Quality control (QC)
 The number of the SOP
13

14.  WP6-this SOP being written under WP6
 QUAL-this SOP is related to quality
 01-this is SOP n01 of the quality type
 If the procedure is lengthy one, then the description of
the procedure can be split up & placed under smaller
headings.
 On each page of the SOP indicate:
The SOP number, the version number & date
The page number & the total number of pages
SOP N0 WP6-QUAL-01
14

15.  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.
 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. 15

16. 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 something under
conditions. Instead be positive & tell them what
to do.
16

17. General format for SOP
17

18. 18

19. 19

20. Persons having authorization may include:-
 Nominee of local staff, expert in his own field &
familiar with GMP
 General manager (Production)
 General manager (Quality Control)
 General manager (Quality Assurance)
 Nominee of management (may be technical
director)
20

21. Sop process
 Sop Preparation
 Sop Review & Approval
 Frequency of revisions & reviews
 Implementing SOP
 Management of SOP
21

22. Sop preparation
should be written by individual knowledge with the activity &
subject matter experts.
 Those who will perform job
 Those who will perform maintenance on equipment
involved in an SOP
 Technical initiator
 Safety personnel
 Engineers or others who design equipment & process
 Environmental personnel
 Equipment manufacturers
22

23. SOP review & approval
Review factors & criteria are:-
 Adherence to standard
 Consistency & traceability
 Readability, comprehensibility,& general understandability
 Technical adequacy & feasibility of approach
 Degree of completeness
 Testability of requirements
 Use of appropriate requirement, design, or coding
techniques
 Appropriate level of details
23

24. SOP Revisions
Routine revision:-
 At the end of the review period by HOD concerned
to the particular SOP will review & revise if
required.
 If there is no changes then HOD just gives the
review report that this SOP doesn’t require review
& continue the same for the next review project.
24

25. Implementing SOP
 The most important step for SOP in working area,
train or retain the user.
 While training the user, trainer should share the
reason WHY,SOP must performed correctly.
People are much more to follow when they
understand importance of procedure.
25

26. Management of SOP
 There should be the record for issue &
distribution of the SOP’s.
 It is the responsibility of the process owner to
 Ensure that SOP’s are current.
 Distributes SOP’s.
 Eliminate obsolete SOP’s.
 Continuously improve the system.
 Ensure that SOP’s meet their quality requirement
& are user friendly.
26

27. What kind of SOPs are needed?
 Routine instrument maintenance?
 Glassware washing?
 QAU?
 Computer?
 SOP for SOPs?
 Analytical method?
 Specific procedure for initial research project?
27

28. Types of SOP
 SOP’s may be written for any repetitive TECHNICAL activity,
as well as for any administrative or functional programmatic
procedure, that is being followed within an organization.
 The types of SOP’s are:
1)Technical SOP:-focuses more on technical activities such as
how to collect a laboratory sample & how to fix the R2 engine.
2) Administrative/fundamental programmatic SOP:-highlights
on the administrative process such as reviewing contract
documentation & determining organizational training needs.
28

29. Reasons for having SOP’s
 To provide people with all the safety, health,
environmental & operational information.
 To ensure that no failure occur in any processes.
 To ensure that approved procedures are followed in
compliance with company & government regulations.
 To serve as an historical record of the hole process
which is done & have a basis of that when the process
is changed.
 Provide training & guidance for new staff.
29

30. Content of sop
 Company name & pagination
 Title
 Identification
 Review & Approval
 Purpose
 Scope
 Responsibility
 Procedure
30

31. Content of sop
1)Company & pagination:- the company &
pagination (e.g. page 4-9) must appear on every
page.
2)Title :-the should be descriptive. The title should
use directive language to declare what is being
done to what.
31

32. 3)Identification:-procedure must be easily by giving
unique number & version number. This identification
number of the SOP supports accountability of the
document throughout the facility & over time as it
changes.
4) Review & approval:-all SOP’s shall have space for
signature of
 Initiator (the person who has written the SOP)
 Reviewer (the person who has review the SOP)
 Approver (quality assurance head of the
organization)
32

33. 5) Purpose :- the purpose or objectives of the
procedure should restate & expand
will written title. Expand or qualify the directive
language used in the title (e.g. to describe the
operation procedure of compression machine.)
6)Responsibility :-Who is responsible for performing
the work described? Who is responsible for
implementing the procedure?
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34. 7) Scope:- The scope should provide limits into the use
procedure.
 Where is the SOP to be used & where is not applicable,
e.g. Area, process, department, stage?
 Who is the sop for & aimed at, e.g. Operator, manager,
QA person?
 Are there any specific limitations or expectation that
need to be called out?
8) Procedure:- described the procedure in a step by step,
chronological manner. Use active verbs & direct
statements. 34

35. How to use SOP’s
 Manager use SOPs to communicate to staff & explain how
to perform certain company operations.
 Employees can use SOPs for reference when learning to
complete certain tasks according to established
protocols.
 Regulatory agencies, such as the food & drug
administration, use SOPs when determining whether a
company’s processes meet agency standards.
 Section of fundamental principles can be include :
 Preliminary steps that must be done before beginning of
actual procedure.
 Safety consideration.
 The chronological instructions.
 Calculations. 35

36. SOP DEVELOPMENT
36

37. Master batch record
 Master batch record, also known as Master
Production Records.
 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 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. 37

38. 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 38

39. 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 39

40. 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.
40

41. 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 41

42.  Packaging requirement
 Packaging instructions
 Precaution to be taken
 Finished product specification
 Expiry date
 Review due on.
42

43. Conclusion
 SOP’s serve as fundamental means of communication for
all levels of the organization.
 Not only do they involve employees departmentally, but
they also allow management & employees to gain a cross-
functional view of organization.
 This approach encourages employees to think about how
process change may affect other functional areas.
 It shall be noted that the best written SOP’s will fail if
they are not followed.
 A good system forces employee to think through processes
& examine how procedure might affect product,
personnel, production, & equipment.
43

44. 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
6)Quality assurance book by D H Shah 2nd edition pg. no.2-6
7) SOP Guideline book by D H Shah 4th edition pg. no2-10
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45. 45
Thank you