SOP (Standard Operating Procedure)
1.2
Introduction
1.3
Good Manufacturing Practice
Good Manufacturing
Practice (GMP) is a system for ensuring that products are consistently
produced and controlled according to quality standards. It is designed to
minimize the risks involved in any pharmaceutical production that cannot be
eliminated through testing the final product.
1.4
SOPs
A standard operating procedure, or SOP,
is a set of step-by-step instructions compiled by an organization to help
workers carry out complex routine operations. SOPs aim to achieve
efficiency, quality output and uniformity of performance, while reducing
miscommunication and failure to comply with industry regulations.
The quality assurance
department is responsible for providing support to the parent company,
affiliates, and contract manufacturers in the development, upgrading, and
maintenance of GMP requirements. Validation SOPs is required to give
step-by-step direction in performing validation.
Ø Efficiencies,
and therefore profitability.
Ø Consistency
and reliability in production and service.
Ø Fewer
errors in all areas.
Ø A
way to resolve conflicts between partners.
Ø A
healthy and safe environment.
Ø Protection
of employers in areas of potential liability and personnel matters.
Ø A
first line of defense in any inspection, whether it be by a regulatory body, a
partner or potential partner, a client, or a firm conducting due diligence for
a possible purchase.
Ø Value
added to your business should you ever wish to sell it.
1.5
Validation Process
Ø Action
of proving, in accordance with the principles of good manufacturing practice,
that any procedure, process,
equipment, material, activity, or system actually leads to the expected result.
Ø Documented
evidence which provides a high degree of assurance that a specific process will
consistently produce a product meeting its predetermined specifications and
quality attributes and characteristics.
Ø Obtaining
and documenting evidence to demonstrate that a method can be relied upon to
produce the intended result within defined limits.
2.1.1
SOP
Preparation
Ø SOP
should be written by individuals knowledgeable with the activity.
Ø These
individuals are essentially subject-matter experts who actually perform the
work or use the process.
Ø SOPs
should be written with sufficient detail so that someone limited. Experience
with or knowledge of the procedure, but with a basic understanding, can
successfully reproduce the procedure unsupervised.
2.1.2
SOP
Review and Approval
Ø SOPs
should be reviewed by one or more individual with appropriate training and
experience with the process.
Ø The
finalized SOPs should be approval as described in the Organization’s Quality
Management Plan or its Master SOPs.
Ø Generally
the immediate supervisor and organization’s quality assurance officer review
and approval of SOPs.
2.1.3
Revision
and Reviews
Ø Whenever
procedures are changed, SOPs should be updated and re-approved.
Ø If
desired, modify only the pertinent of an SOP and indicate the change
date/revision number for that section in Table of contents.
Ø SOPs
should be also systematically review on a periodic basis, e.g. every 1-2 year,
to ensure that the procedure remain current and appropriate.
Ø The
frequency of review should be indicate by management in organization’s Quality
Management Plan.
2.1.4
Implantation
SOPs
Ø Organization
shall have SOP on preparation, approval, revision and control of Standard
Operating Procedure for better control and management of SOPs.
Ø Generally,
administrative aspects of the SOP system such as distribution and filing are
well managed. On the other hand, overall system management, frequency characterized
by the lack of a system owner, is generally poor. If system owner exists at
all, his or her responsibility are limited.
Name of Facility
_____________________________________________ Page________ Of ____
|
SOP Number _____________ Tittle ______________________________________________
Revision By _________________
Written By
_____________________________ Edited By______________
Authorization Signature
____________________ Department _____________ Date__________
Effective Date _________________________________
Replaces _______________
|
Purpose:
WHY:
Why is this procedure written?
Why is a being perform?
|
Scope:
WHEN:
Indicate when this procedure needs
to be performed.
WHERE:
Indicate where this procedure
applied
|
|
Material and Equipment
WHAT: What is needs to perform the
test? The list should be completely specific.
|
3.1 Generation and Validation of
SOP for Autoclave
3..2 Purpose:
This
SOP provides an authorized procedure to carry out calibration & validation
of Autoclave.
3.3 Scope:
This
SOP provides the relevant methodology for the calibration and validation of
Autoclave.
3.4 Responsibility:
Microbiologist
3.5 Accountability:
Manager-Quality
Control
3.6 Definition:
· An
apparatus in which special conditions (such as high or low pressure or
temperature) can be established for a variety of applications; especially: an
apparatus (as for sterilizing) using steam under high pressure.
· A quality assurance procedure used
to ensure that the autoclave reaches adequate temperature for an adequate
amount of holding time to sterilize biological agents and wastes.
Will demonstrate that adequate
temperature and holding time has been achieved in an autoclave; should be used
during validation to ensure efficient sterilization. The most commonly used biological indicator
is Bacillus stearothermophius, being
the most resistant to steam autoclaving.
Autoclave
3.7
Procedure:
3.7.1
Calibration:
- ·
Calibrate the temperature indicator,
pressure gauge and probe once in a year by external agency or whenever any
replacement or maintenance done on the apparatus.
- ·
Place the Benzoic acid AR grade as a
chemical indicator for temperature calibration in regular sterilization cycle.
It melts at 121°C.
Maintain the records, and abort the
particular load used for calibration.
3.7.2
Validation:
- Perform the validation of autoclave
during installation of Equipment and revalidation.
- Heat distribution studies on empty
chamber 3 times by using a multi-point data logger.
- All probes must reach temperature 121°C
to 124°C. Pressure must be within 15 to 18 lbs maintain the same for 15 minutes
cycle.
- Heat distribution studies on minimum
load of a load pattern one time by using a multi-point data logger.
- All probes must reach temperature 121°C
to 124°C. Pressure must be within 15 to 18 lbs maintain for 15 minutes, &
find the lag time.
- Heat distribution studies on maximum
load of a load pattern three time by using a multi-point data logger.
- All probes must reach temperature 121°C
to 124°C. Pressure must be within 15 to 18 lbs maintain for 15 minutes, and
find the lag time.
- Heat penetration studies on minimum load
of a load pattern three times by using a multi-point data logger.
- All probes must reach temperature 121°C
to 124°C. Pressure must be within 15 to 18 lbs maintain for 15 minutes, and
find the lag time.
- Heat penetration studies on maximum load
of a load pattern three times by using a multi point data logger.
- All probes must reach temperature 121°C
to 124°C. Pressure must be within 15 to 18 lbs maintain for 15 minutes, and
find the lag time.
- With the above heat penetration study
the maximum lag time plus 15 minutes is regular operating cycle of the
validated load pattern.
3.7.3
Microbial Challenge Test:
- Keep spores suspension of Bacillus
Stearothermophilus of having population 10 6 at various location of the
autoclave along with probes during maximum load heat penetration study.
- Sterilized spore ampules incubate at
55° to 60°C for 120 hours.
- Spore ampules should not show any
colour change at the end of the incubation.
3.7.4 Cleaning:
- ·
Ensure that the equipment is isolated
from the power before starting the cleaning activity.
- ·
The outside of the autoclave should be
wiped with a wet sponge and allow to dry.
- ·
Clean the chamber with 0.1% SLS solution
using the sponge.
- ·
Wash thoroughly with purified water till
get free from the detergent.
4.1
Generation and Validation of SOP for Dissolution Apparatus
4.2
Purpose:
This SOP provides an authorized procedure to carry
out calibration & validation of
Dissolution Apparatus.
4.3
Scope:
This Procedure is applicable to all dissolution test
apparatus, installed in quality control laboratory
4.4
Responsibility:
Doing: Worker
Checking: Executive/Manager
4.5
Accountability
Head of Department
4.6
Definition:
Tablet Dissolution is
a standardized method for measuring the rate of drug release from a dosage form
and the key word here is “standardization" because for any results to be
meaningful, it is essential that all the apparatus used for the testing, produces the same sets of results
given all other parameters are equal.
A dissolution test is a means of
identifying and proving the availability of active drug materials in their
delivered form. A dissolution test simulates
the availability of active substance and allows the prediction of the time for
complete release of the material from the dosage form.
Dissolution
Test Apparatus
4.7
Procedure:
·
Raise the motor driven to upper side by
Up/Stop/Down Switch.
·
Switch OFF the instrument.
·
Switch OFF the main.
·
Cleaning Procedure for the apparatus
4.7.1
RPM Setting:
·
Press the RPM key from the front panel.
·
Set the RPM from 25 to 200 using the UP
/ DOWN / DIGIT SCROLL key as per requirement.
·
To start or stop the stirrer use F1 or
F2 keys respectively.
4.7.2
Temperature Setting:
·
Press the TEMP key from the front panel.
Set the temperature from 30.0°C to 40.0°C by using UP / DOWN / DIGIT SCROLL
key.
·
Switch heater ON/OFF BY using the
function key F1/F2 Press ENTER key to register the change.
·
“TEMP ON” LED on the front panel will
glow after switching on heater. The pump and the Heater ON LED on temperature
Controller Unit will glow.
4.7.3
Frequency: After Completion of every dissolution test:
·
Remove the bowl from the its place
discard the medium of bowl and wash properly with purified water then keep
inside the dissolution bath number wise.
·
Remove the basket from basket apparatus
and then paddle/basket from dissolution test apparatus with the help of key,
wash them purified water, dry with tissue paper and keep at proper place.
·
Keep the record in the instrument log
card.
·
Cleaning procedure for water bath of
dissolution test apparatus.
4.7.4
Frequency: Once in the week or whenever necessary:
·
Remove the all bowls from the water bath
and the apparatus.
·
Remove the lid of the water bath and
discard all the water from the water bath.
·
Wash the bath with raw water, detergent solution
and raw water sequentially unit no foam of detergent remain in the water bath.
After complete removal of the detergent wash the bath with purified water.
·
Keep the bath to it’s the original place
and clean the dissolution apparatus.
·
Record it as per Annexure
·
Put the lid of water bath and fill
medium in the apparatus. Fill the bath with purified water up to level mark.
4.7
Power Fail Condition:
·
During test running time, if the Power
fails then the Power Failure screen will be displayed when the power is resumed
back.
·
The user can either start the test again
or can stop the test by pressing the F1 or F2 key respectively.
·
If the F1 key is pressed, then the test
will start from the point it has stopped and the instrument will display the
Run Screen again.
4.8
Sample Withdraw Procedure:
Withdraw sample from a zone midway between the
surface of the dissolution medium and top of rotating basket/paddle, not less than
10 mm from wall of vessel.
4.9
Dissolution Medium Preparation:
Prepare the dissolution
medium as per specified under monograph or procedure, filter through 0.45 mm
filter paper under vacuum and stirring.
Note:
Replace the water from the bath weekly or early if required.
