2- How to write Good SOP

How to write Good
SOP
STANDARD OPERATING
PROCEDURES.(SOP’S).
INTRODUCTION :
• KEYWORDS :
• SOP – Standard Operating Procedure
• Step – by – step instructions.
• For effectiveness and efficiency.
• BACKBONE OF EVERY PHARMACEUTICAL INDUSTRY.
• Standard Operating Procedures (SOPs) are essential for any plant’s
effectiveness and efficiency, and they are a regulatory requirement in
the pharmaceutical industry
W H Y I S IT E S S E N T I A L ?
The manufacturers of health care products rely on precision, rigor and
consistency to produce reliable products for patients, physicians and
consumers, time and time again. To drive the kind of culture that consistently
and effectively produces results of this nature, companies must first create a
culture where quality objectives are transparent, well understood, and acted
upon routinely, and thus the need to develop a well maintained record of
every correct procedures carried out came, which was known as
Standard Operating Procedures (SOP’s).
FDA’S T H R E E G O L D E N R U L E S
ON PROPER
DOCUMENTATION
1. If it isn’t written down, it didn’t happen.
2. If it isn’t written down properly, it didn’t happen
either.
3. Never forget Rule 1 and 2.
AIMS .
 To maintain the equilibrium in quality control and quality assurance.
The purpose of an S O P is to carry out the operations correctly and
always in the same manner.
Uniformity of performance.
To serve as a reference for teaching purposes about the process for
which the S O P was written.
It should be available at the place where the work is done.
Elevate the status of pharmacists and enhance their motivation
for better performance.
 Reduce miscommunication and failure to comply with industry
regulations.
 To provide guidelines for accurate and on time data collection.
GENERAL AREAS COVERED BY SOP
 S O P for The Role and Responsibilities of the (QPPV) .
 S O P for The follow-up of Reports for missing information.
 S O P for Expedited Reporting, Processing and Submission of
Individual Case Safety Reports (ICSRs)
 S O P for Literature Screening Procedure S O P for Drug Storage
 S O P for Meeting commitments with national medicines authorities,
 including provision of correct and complete information
 S O P for Archiving of documents relevant to Pharmacovigilance
 S O P for PV inspections Readiness
 S O P for Handling of urgent safety restrictions and safety variations.
 S O P for Signal Detection, Identification and Evaluation
CONTINUED
. Periodic Benefit Risk Evaluation Report (PBRER)
 S O…
P for
 S O P for Interaction between the pharmacovigilance and product
 quality defect systems
 S O P for A d d e n d u m t o C l i n i c a l O ve r v i e w ( A C O )
 S O P f o r Establishing, assessing, and implementing risk management
systems
and evaluating the effectiveness of risk minimization
S O P for Dear doctor letter (DDL) Reporting, Communicating &
Notifying HCPs of
S O P for Cross departmental input To PV activities
S O P for Ensuring the fulfillment of PASS/PAES obligations
S O P for Communication about safety concerns between marketing
authorization holders and national medicines authorities, in
particular notifying changes to the risk-benefit balance of
medicinal products
T Y P E S O F SOP’S
Fundamental SOP : These gives instructions how to make SOP’s of other
categories.
Methodical SOP : These describe a complete testing system or method of
investigation
 Analytical method
 Preparation of Reagent
 Quality Assurance
 For operating instruments, equipment and apparatus
 Safety & Precautions
 Receiving and registration of sample
 To deal with complaints
S O P WRI T I NG S T Y L E :
• SOP’s shall be written in a concise, step by step, easy to read and 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.
CONTENTS OF SOP
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•
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•
•
•
•
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Company name and pagination
Title
Identification
Review and approval
Purpose
Scope
Responsibility
Procedure
PROCESS OF SOP
 SOP Preparation
 SOP Review and Approval
 Frequency of revisions and reviews
 Implementing SOP
 Management of SOP
P A R E NT E R AL PREPARATIONS:
• Parenteral term is derived from Greek word Para meaning
Outside, and Enterone meaning Intestine.
• Parenteral preparations are sterile preparations containing one
or more active ingredients intended for administration by
injection, infusion or implantation into the body.
• CLASSIFICATION :• Parenteral preparations are of 2 types:a. Large volume parenterals.
b. Small volume parenterals.
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.
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.
• Because SOP’s are a set of INSTRUCTIONS,
not CONDITIONS.
Q U E S T I O N S F R E Q U E N T L Y ASKED:• S H O RT N OT E S :
• Standard Operating Procedures for parenteral
preparations.
{OR}
• S O P of any one dosage form. {OR}
• SOP.
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[email protected]
[email protected]
[email protected]
Dr. Aya Harb (QPPV)
01069348418
Dr. Mina Diaa (Deputy Qppv)
01201753565
Pharmacovigilance
Department