Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Formula Record, how to write SOP, Sop Content, MFR Content
1. Standard Operating
Procedure in
Pharmaceutical
Industries
Prepared by: Simran Kukreja
Guided by: Dr. Ajazuddin (Professor)
Product Development Laboratory
Rungta College of Pharmaceutical Sciences
and Research, Bhilai, C.G., 490023
Email: simrankukreja.pharmacy@gmail.com
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2. CONTENT
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1. Standard Operating Procedure
- Introduction
- Objectives
- Benefits
- Types of SOP
- SOP Writing Style
- DO’s
- Don’ts
- SOP Content
- SOP Process
- SOP for Tablet Compression
2. Master Formula Record
- Content
3. INTRODUCTION
• 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 and time
constraints.
SOP - AIM FOR QUALITY
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4. OBJECTIVES
• To maintain the quality control and 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 and to support data quality.
• To provide guidelines for accurate and timely data
collection.
• Uniformity of performance.
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5. Contd…
• Efficiency and quality output.
• Reduce miscommunication and failure to comply
with industry regulations.
• To carry out operations correctly and always in
same manner.
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6. BENEFITS
• Provides information to perform job properly.
• To provide people with all safety, health, environmental
and operational information necessary to perform the
job properly.
• Serves as a training document for users.
• Minimizes variation and promotes quality. Steps can be
reviewed in accident variations.
• Also provide, consistency(very important).
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7. Contd..
• Useful tool for training new members of staff.
• SOP assist to ensure that GMP is followed and
achieved at all times.
• SOP’s help to assure the quality and consistency of the
services, and thus minimize harm to the patient.
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8. TYPES OF SOP
• Analytical method
• Preparation of Reagent
• Quality Assurance
• For operating instruments, equipment and
apparatus
• Safety & Precautions
• Methodic
• Receiving and registration of sample
• Fundamental SOP
• To deal with complaints
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9. 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, and
present verb tense should be used.
• Should be simple and short.
• Routine procedures that are short and require few decisions
can be written using simple steps format.
• Long procedures consisting of more than 10 steps, should be
written along with graphical format or hierarchical steps.
• Procedures that require many decisions should be written along
with flowchart.
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10. 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 and be concise.
• Reduce the word count where possible without changing
the meaning of the text.
• Keep the words short and get to point.
• Highlight exceptions. Use a symbol to flag that this is an
exception and how to handle it.
•Highlight warnings and use a larger or a warning icon.
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11. 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 and tell them what to do.
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12. CONTENT OF SOP
• Company name and pagination
• Title
• Identification
• Review and approval
• Purpose
• Scope
• Responsibility
• Procedure
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13. SOP PROCESS
• SOP Preparation
• SOP Review and Approval
• Frequency of revisions and reviews
• Implementing SOP
• Management of SOP
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15. SOP - TABLET COMPRESSION
• Clean the compression machine as per respective SOP.
• Make sure that the compression area has been clean
properly.
• Clean the dust extractors, its pipes, racks, door frames
and return filters of Air Handling Unit.
• Check it visually for intactness and absence of leakage.
• Intimate quality control department to collect swab
samples as per requirements.
• After receiving the approval from QC department put
‘’cleaned label” to all equipments.
•
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16. Contd…
• Clean with 70% isopropyl alcohol before taking
clearance from QC department.
• As compression of product is to be started, remove the
‘cleaned status’ and affix label to the machine along with
product name & Batch details.
• Issue the punch set suitable for the compression as per
SOP.
• Set the compression machine as per SOP and check the
setting of machine.
• Set the machine as per tablet parameters given in BMR.
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17. Contd..
• Destroy the tablets of first few rotations before starting
the machine for the compression of batch as per SOP.
• Collect the tablets generated during machine setting in a
container. Keep it label & pack.
• Stop the compression as the material in the hopper
reaches the lowest level.
• Clean all the containers from outside & transfer it to
store with label having all batch details.
• Remove the punch sets and clean it as per the SOP.
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18. MASTER FORMULA RECORD
• A Document or set of documents specifying the starting
materials with their quantities and the packaging
materials, together with a description of the procedure and
the precautions required to produce a specified quantity of
a finished product as well as processing instructions,
including in process controls.
• MFR can also be said and written as ‘ Master Formulae’,
‘Manufacturing Record’, ‘Master Production and Control
Record’.
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19. It includes
• Batch Manufacturing Records(BMR)
• Batch packing record(BPR).
• Intermediate/ packing material/ finished product
specifications.
• Specimen of printed packaging material.
• All documents of “ Master Formula Record” should be
stamped as “ Master Copy” in green at the non text
side(back side).
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20. CONTENT OF MFR
• the name of the product together with product reference
code relating to its specifications.
• the patent or proprietary name of the product along with
the generic name, description of the dosage form strength,
composition of the product and batch size.
• a statement of processing location and the principle
equipments to be used.
• the name, quantity, and the reference number of starting
material to be used.
• a statement of expected yield with acceptable limits and
relevant intermediate yield, where applicable.
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21. Contd..
• the methods, or reference to the method, to be used for
preparing the critical equipments including cleaning,
assembling, calibrating, sterilizing.
• detailed step wise processing instructions and the time
for each step.
• the instructions for in process control with their limits.
• the requirements for storage conditions of the products,
including the container, labeling and special storage
conditions where applicable.
• any special precaution to be observed and packing
details and specimens label.
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