1.0 OBJECTIVE:
To describe the procedure for conducting stability studies for the drug products in order to establish appropriate expiration and storage condition.
2.0 SCOPE:
The scope of this SOP is to provide the procedure for stability Study initiation, monitoring, collection of sample and compilation of stability data.
3.0 RESPONSIBILITY:
3.1 Quality Assurance personnel to coordinate stability study. Responsibility of Stability coordinator as per Annexure – 7
3.2 Analyst(s) for analysing the stability samples.
3.3 Raw Material store personnel to intimate QA Department regarding Active pharmaceutical ingredient (API) received from new vendor.
3.4 Head QA to ensure the compliance.
4.0 PROCEDURE:
4.1 REASONS FOR CONDUCTING STABILITY STUDIES
The stability study shall be performed for the following reasons:
4.1.1 Introduction of new product/new process.
4.1.2 Change in the manufacturing process / critical process parameters, Significant change in the batch size.
4.1.3 Change in critical equipment of the manufacturing process.
4.1.4 Change in container and closure.
4.1.5 Reprocessing for the first time.
4.1.6 Change in Composition and Component of drug product.
4.1.7 Change in facility/location.
4.1.8 For regulatory purposes.
4.1.9 Change in the storage conditions.
4.2 SELECTION OF BATCHES:
The following procedures shall be followed for the selection of batches, for stability studies:
4.2.1 New product / new process:
4.2.1.1 Bio batch (Exhibit batch) shall be kept in stability as per the requirement and first three validation batches shall be kept in stability.
4.2.1.2 In case of product for domestic market after the process optimization, 3 successive commercial batches shall be kept at all three conditions mentioned below.
– Accelerated conditions of 40°C ± 2°C / 75% RH ± 5% RH
– *Long term conditions of 25°C + 2°C / 60% RH ± 5% RH
or 30°C + 2°C / 65% RH ± 5% RH
– **Intermediate conditions of 30°C + 2°C / 65% RH ± 5% RH or as per the regulatory requirements.
* It is as per recommended storage condition whether long term stability studies are performed at 25°C + 2°C / 60% RH ± 5% RH or 30°C + 2°C / 65% RH ± 5% RH.
** if 30°C + 2°C / 65% RH ± 5% RH is long term condition, there is no intermediate condition.
4.2.1.3 In case, the product by nature is known to be temperature sensitive, the storage conditions shall be different. This shall be appropriately decided by QA in consultation with R&D and Regulatory Affairs.
4.2.1.4 Regular study – Anyone from the first three batch of the year and any one from the first three batches after every 100th batch in a year shall be kept for long term stability study.
4.2.2 Major Process/ Equipment Change (After regularization)
After a major change in manufacturing process or critical equipment, which warrants stability study requirement, three production batches shall kept for stability study in accelerated, intermediate and long-term condition.
4.2.3 Change in batch size
After a significant change in batch size, which warrants stability study requirement, one production batch shall kept for stability study in accelerated, intermediate and long-term condition.
4.2.4 Change in container and closure:
The stability study shall be carried out for change in container and closure of drug products as per Annexure 13.
Type 0, Type 1, Type 2, Type 3 are data packages which is required as per Annexure 14
4.2.5 Reprocessing
In case Reprocessing for a product is performed for the first time, the
reprocessed batch, shall be kept on accelerated stability study and long term
Stability study.
4.2.6 Change in Composition and Component of drug product:
Level 1: Those that are unlikely to have any detectable impact on formulation quality and performance.
E.g. Partial deletion or addition of ingredient quantity, color, flavor.
Change in excipients less than or equal to the following percentage.
These percentage are based on 100% label claimed formulation. Total change shall not be more than 5%.
Onebatch shall be kept for stability study in long-term condition in case of level 1 change.
Level 2: Change those that could have significant impact on formulation quality and performance
E.g. a. change in technical grade of excipients, partial change in excipients percentage of total formulation, greater than those listed above for a level 1 change but less than or equal to following percentage.
These percentage are based on 100% label claimed formulation. Total change shall not be more than 10%.
b. Change in the vendor source of active pharmaceutical ingredient
One batch shall be kept for stability study in accelerated and long-term condition in case of level 2 change.
Note: Raw material store personnel shall give intimation for vendor change of API in existing product as per Annexure 12 to QA Department and the intimation shall be in duplicate. One copy shall remain with store and one copy shall handed over to QA department.
Level 3: Changes are those that are likely to have a significant impact on formulation quality and performance.
E.g. Any change beyond defined in level 1 with narrow therapeutic drug, Changes in the excipients ranges of all drug beyond those defined in level 2 E.g. , a. One batch shall kept for stability study in accelerated and long-term condition in case of level 3 change.
4.3 STABILITY STUDY CONDITIONS / INTERVALS
@ At accelerated Storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3 and 6 month)
$ Intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of four time points, including the initial and final time points (e.g. 0, 6, 9, 12 months)
NOTE : 1).Bulk pack in which there is a requirement of repackaging, stability study shall be performed at accelerated condition for 1 month and long term condition for 3 months (Frequency: Initial & 3 months)
2) After getting the result of analysis from Analyst(s) if there is delay (By more than one month) in loading the samples in stability chamber reanalysis shall be done and reanalysis results shall be considered as an initial results
3) Reduce designs, i.e. matrixing or bracketing, where the testing frequency is reduced or certain factor combination are not tested at all, can be applied, if justified.
4) If the stability study at intermediate storage condition need to perform, same shall be mentioned in protocol.
4.4 STABILITY PROTOCOL:
4.4.1 Before starting the stability studies for a given reason, a Stability Protocol (SP) shall be prepared by QA Personnel and approved by Quality control and Quality Assurance. QA personnel shall load the samples as per the stability protocol in stability study chamber within 7 days from the date of approval of protocol.
Note: Annexure –1 shall be used as guidance for the preparation of stability protocol, contents shall be changed as per the product requirement.
4.4.2 Based on the Stability Study Protocol, a Stability Study schedule shall be prepared by QA personnel.
4.4.3 Each protocol shall be identified with unique numbering system. It consists of 10 Characters.
4.4.3.1 First two characters are “SP” indicates stability protocol.
4.4.3.2 Third character indicates the market, “R” indicates regulatory market, and “D” indicates domestic market.
4.4.3.3 Fourth characters is “/ “ (Slash).
4.4.3.4 Next three characters are serial No for stability protocol starting from 001 for period from January to December.
4.4.3.5 Next characters is “ / “ (Slash ).
4.4.3.6 Last two characters indicates year ( ie 2008 as 08 etc.).
4.4.3.7 Control register for numbering of protocols shall be maintained by QA with details like S.No, Protocol No, Product name, Batch No, reason for conducting stability study, Allotted by QA personnel, Approved by Head QA as per Annexure – 9.
4.5 SAMPLING, PACKING, LABELING
4.5.1 IPQA personnel shall perform sampling of the batches to be kept on stability studies, as per stability testing requirements. Samples shall be representative of complete batch i.e. collect in regular interval.
Calculate the minimum sample quantity as per the below given Formula:
No of Units (e.g. Tablets/Capsules, etc) Required for one complete Analysis x 2 x Total No. of stations (Accelerated+ Intermediate+ Long Term)
Stability sample Should be labeled as per annexure 11.
Withdraw the sample in intact pack. If quantity of units (Tablets/Capsule) differs than the last full pack is to be withdrawn.
4.5.2 The stability samples wherever possible shall be kept in market pack only. In case of bulk pack etc. required number of quantity of sample can be collected in a suitable container/closure system, which simulates the market pack as far as possible and shall be labeled with all necessary details like Product, B. No, Mfg. Date, Exp. Date, loaded on and condition.
4.5.3 Separate samples shall be collected for microbiology if it is required.
4.5.4 Stability samples shall be kept in control storage area (below 25°C) until the approval of the batch / stability study initiation.
4.6 STABILITY CHAMBERS MONITORING:
4.6.1 The stability chambers shall be monitored for temperature and relative humidity and records shall be maintained.
4.6.2 Take printouts of the environmental monitoring record by using the stability Data Acquisition Software every working day.
Note: Mean kinetic temperature (MKT) is defined as the isothermal temperature that corresponds to the kinetic effects of a time-temperature distribution.
4.6.3 The yearly MKT for the preceding twelve months should be calculated every month.
4.6.4 If there is any excursion/deviation from the tolerance limits of temperature or RH.
4.6.5 Excursion that exceed the defined tolerance for more than 24 hour should be Documented and their impact shall be assessed through incident report otherwise the excursion observed below 24 hour are recorded and concluded in Temperature monitoring record.
4.6.6 Job maintenance request shall be sent to the maintenance department for rectification.
4.6.7 The breakdown and restoration of the stability chamber shall be well documented by the QA personnel and maintenance department.
4.6.8 The “sign-in” and “sign-off” records shall be maintained for samples (in a log book), as and when the samples are charged in and removed out from the stability chambers as per stability chamber usage log book (Annexure – 3).
4.6.9 Procedure for BackUp of Temperature and Relative Humidity Data from Stability Data Acquisition Software.
4.6.10 Procedure for Restore of Temperature and Relative Humidity BackUp Data to Stability Data Acquisition Software as per requirement.
4.7 STABILITY SAMPLING AT SCHEDULE TIME POINT
4.7.1 Quality Assurance personnel shall withdraw the samples for analysis as per the stability study schedule (Annexure-2) and details shall be entered in respective stability chambers log books (Annexure-3).
Note: Summary schedule shall be prepared from the stability study schedule (Annexure-2) and shall be verified. Summary schedule shall be used at the time of withdrawal of stability samples.
After withdrawal and analysis of sample the remaining printed packaging material like show box, leaflets, empty strip, bottles etc. shall be cut into pieces or with any other suitable means to destroy its identity and same shall be send to scrap for disposal or shall be kept in west been kept outside of the stability chambers
4.7.2 Sampling of stability sample shall be done with in + 3 days form the schedule date.
4.7.3 QA shall raise the stability analysis request and report for analysis (Annexure – 4), Label the samples with sample for testing (Annexure – 6) and send samples along with the request to Analyst(s) for analysis. The top part of the request above the doted line shall be destroyed after receiving the record of analysis for Stability Study from Analyst(s)
Note: Sample shall kept below 25° C during the analysis period.
4.7.4 The tolerance allowed from the due date of analysis of stability sample (s) shall be 15 days from the date of sample withdrawn from the stability chamber and submission of report to QA shall be 7 working day from completion of analysis, any deviation from the target date shall be justified.
4.7.5 The remaining samples after complete testing at all intervals and samples of discontinued batches shall be disposed as per standard procedure.
4.7.6 The stability study test results shall be properly recorded in the record of analysis for Stability Study Sheet. All primary data print outs/chromatograms shall be checked and filed properly along with record of analysis.
4.8 REPORTING
4.8.1 The stability test results shall be recorded in the Stability analysis request and report by Analyst(s).
4.8.1.1 As soon as the analysis is completed and results are calculated Analyst(s) shall check the previous trending.
4.8.1.2 In case of any abnormalities are observed / significant change:
Prepared solutions shall not be discarded, incident report / OOS report shall be raised, and shall be investigated as case may be.
4.8.2 In General “Significant Change” for a drug product (E.g. tablet / Capsule) is defined as:
4.8.2.1 A 5 % change in assay from its initial value or failure to meet the acceptance criteria for potency.
4.8.2.2 Any degradation product’s exceeding its acceptance criteria.
4.8.2.3 Failure to meet the acceptance criteria for appearance, physical attributes and functionality test (e.g. color, hardness). However some changes in physical attributes may be expected under accelerated conditions as appropriate for the dosage form.
4.8.2.4 Failure to meet the acceptance criteria for dissolution for 12 dosage units.
Note: For Stability indicating Parameter refer the stability specification for stability parameter to be check for stability of individual product or/ otherwise refer the SOP “Procedure to list out test for stability Study”
4.8.3 After completion of analysis, Analyst(s) shall send back the stability analysis request and report along with analysis report to QA Department for there review and compilation.
4.8.4 QA personnel shall check the report and results shall be compiled for each station in the summary report as per Annexure 8 with trend of previous station.
Note: Annexure –8 shall be used as a guidance for the preparation of stability summary report; Summary report can be formatted as per requirement bases.
4.8.5 The trend of results shall be reviewed at each station within seven working days of submission of results from Analyst(s). Graphical representation wherever applicable for critical stability parameters shall be prepared for all stations once in a year for the period of January to December. The graphs are to be compiled within January of current year for review of previous year Data.
4.8.6 In case of confirmed stability failure the same shall be communicated to Head of R & D, Head Corporate Quality and Head of Regulatory Department (wherever required) by Head QA.
4.8.7 The stability study shall be discontinued in case of failure to comply with the specification. Written approval of Head QA and Head corporate QA shall be taken to discontinue the stability study prior to study discontinuation.
4.8.8 The investigation for failure shall be conducted with the help of R & D. The investigation shall be extended to other batches manufactured under similar condition and / or other batches, which are likely to be affected. The recall shall be initiated whenever required as per SOP on ‘Product Recall’.
4.9 DISCONTINUATION OF STABILITY STUDY
4.9.1 Stability study shall be discontinued in case product related problem, product discontinued from the market or any other reason with justification.
4.9.2 QA shall raise stability study discontinuation form (Annexure-5) duly approved by Head QA and Head CQA. An intimation in this regard shall be sent to Head of QC, R & D, Regulatory and the Plant Head. Stability study discontinuation form shall be kept along with the protocol.
4.10 EXPIRATION DATING/RETEST PERIOD
4.10.1 QA shall propose on Expiration Dating of products based on available stability studies data as follows:
4.10.2 In case of a new product/new process, with satisfactory accelerated data at 40°C ±2°C / 75%RH ±5% RH, of 3 months, an Expiration of 2 years can be safely proposed.
4.10.3 The Expiration Dating of the product can be extended beyond 2 years, based on available Long term stability data.
4.11 DESTRUCTION OF STABILITY SAMPLES:
4.11.1 The following procedure will be followed for destruction of stability samples in case of discontinuation of stability study and remaining samples if any after stability study completion at a particular condition.
4.11.2 Enter the withdrawal details of stability samples in the Stability Chamber Usage Log Book as per Annexure – 3.
4.11.3 Remove all strips / blister and keep it on one side and leaflets, show boxes and other paper materials on the other side. Defoil the strip / blister. Remove the dosage form from the blister / strip / bottle into a separate double line poly bag. Label them as “Non Recoverable Residue for Destruction”, and dispose it as per standard procedure.
4.11.4 Remains of blister / strip / bottle send them to scrap processing area in double line polyethylene bags duly labeled for shredding and disposal.
Labels on bottle shall be crossed or destroyed by peeled off.
4.11.5 Cut all other pre-printed packing materials e.g. leaflet, show box, cartoon etc. into pieces and transfer the same to scrap processing area in double line polyethylene bags duly labeled for shredding and disposal.
4.11.6 Maintain the record of destruction of the samples in the “Stability Sample Destruction Record register as per Annexure – 10.
4.12 Bracketing and Matrixing of Stability Samples:
4.12.1 Bracketing:
Under Bracketing, the design of a stability schedule such that only samples on the extremes of certain design factors (e.g., Strength, Container Size and / or Fill) are tested at all time points as in full design. The design assumes that the stability of any intermediate level is represented by the stability of the extremes tested.
4.12.2 Matrixing :
Under Matrixing, the design of a stability schedule such that a selected sub set of the total number of possible sample for all factor combination shall be tested at a specified time point. At the subsequent time point, another sub set of samples for all factor combination shall be tested. The design assumes that the stability of each sub set of samples tested represents in the stability of all samples at a given time point. The differences in the samples for the same drug product shall be identified as, e.g. covering different batches, different strength, different sizes of the same container closure system, and possibly, in some cases different container closure systems.
When a secondary packaging system contributes to the stability of the drug product, matrixing shall be performed across the packaging systems.
Each storage condition shall be treated separately under its own matrixing design. Matrixing shall not be performed across test attributes. However alternative matrixing designs for different test attributes shall be applied if justified.
All selected combinations of batch, strength, container size and fill, among other things, shall also be tested at 12 months. In addition, data from at least three time points, including initial, shall be available for each selected combination through the first 12 months of the study. For matrixing at an accelerated or intermediate storage condition, care shall be taken to ensure testing occurs at a minimum of three time points, including initial and final, for each selected combination of factors.
Note:References are – ICH Q1, SUPAC, Guideline for Industry – Stability Testing of Drug Substance and Drug Product
5.0 ANNEXURES:
Annexure-1 Specimen Stability Protocol
Annexure-2 Specimen format of Stability Study Schedule
Annexure-3 Specimen format of Stability Chamber usage log book
Annexure-4 Specimen format of Stability analysis request and report.
Annexure-5 Specimen format of Stability Study Discontinuation form
Annexure-6 Specimen format of Stability Sample for Analysis
Annexure-7 Responsibility of QA Stability Coordinator
Annexure–8 Specimen format of Stability Study Summary Report
Annexure–9 Specimen format of Register for Numbering of Protocols
Annexure–10 Stability Sample Destruction Record
Annexure–11 Specimen format of Stability Study Sample label
Annexure–12 Intimation slip for Vendor change of API
Annexure–13 Stability study in case of container closure changes
Annexure–14 Stability Data Packages
===============================================
Annexure-1 Specimen Stability Protocol
Product:
CONTENTS
1.0 Objective
2.0 Responsibilities
3.0 Stability Plan
4.0 Procedure
4.1 Stability Sample Collection
4.2 Initiation of stability
4.3 Stability Sample Withdrawal
4.4 Compilation of stability data
1.0 OBJECTIVE:
The objective of this protocol is to conduct the stability studies as per the requirement to establish the stability and shelf life of the product.
2.0 RESPONSIBILITY:
2.1 Quality Assurance:
To initiate the stability studies, loading and collection of samples as per the schedule, review and compile the stability data.
2.2 Analyst(s):
To analyze the samples and submit the reports to Quality Assurance Officer(s).
3.0 STABILITY PLAN:
Reason for conducting the stability Study:
3.1 Active Pharmaceutical Ingredient Details
Active Ingredient:
Name and address of the Manufacturer:
3.2 Batch Size:
3.3 Market:
3.4 Pack Details:
3.5 Container/ Closure System:
3.6 No. of units required at each condition (in duplicate):
25ºC/ 60% RH : 30ºC/ 65% RH : 40ºC/ 75% RH
3.7 Test interval According to the storage condition
3.8 Test to be performed at each station
4.0 PROCEDURE:
4.1 Stability sample collection:
4.1.1 IPQA personnel shall collect the samples for stability during packing and initiate stability studies; samples shall be collected as per the SOP. The samples shall be twice the quantity sufficient for complete analysis for each interval.
4.2 Initiation of stability:
4.2.1 After release of batch, QA person shall load samples into stability chambers at respective storage conditions
4.2.2 Loading details of the samples
Batch Details
Container/ Quantity
No. of units
Batch No
Mfg.
Exp.
Loaded by
4.3 Stability sample withdrawal:
4.3.1 QA personnel shall withdraw the samples as per the schedule.
4.3.2 Sample withdrawal shall be done on or with in + 3 days of the scheduled due date.
4.3.3 After sampling, samples shall be forwarded to Analyst(s) for analysis along with Stability analysis request and report.
4.3.4 Analyst(s) shall analyze the samples as per Technical Analytical Document.
4.3.5 Samples shall be stored at below 25 Deg. C till the analysis is complete.
4.3.6 Once the analysis is completed, Analyst(s) shall give Analysis request and report along with record of analysis to Quality Assurance Officer(s) for review and compile.
4.4 Compilation of Stability data
4.4.1 Concerned personnel of the Quality Assurance shall compile the data.
Annexure – 3 STABILITY CHAMBER USAGE LOG BOOK
Equipment No:
Conditions Maintained at:
Calibration Due Date:
USAGE DETAILS
Date
Used for
Entry time
Exit Time
Protocol No
Used by
Remarks
Annexure – 5 STABILITY STUDY DISCONTINUATION FORM (SSDF)
Name of the product
Manufacturing Location
Pack
Batch Number(s)
Manufacturing Date
Protocol No
Reason(s) for Discontinuation
Initiated By
Approved by Head QA
Head CQA
Annexure – 4 STABILITY ANALYSIS REQUEST AND REPORT
Product Name
Storage Condition
Batch No
Duration
Sample Quantity
Requested By / Date
Received By / Date
Content below the dotted line shall be send to Analyst and the above part shall be retained with Stability Coordinator
Date:
Product Name:
Generic Name:
Batch No:
Mfg. Date:
Exp. Date:
Storage Conditions:
Duration:
Pack:
Requested By:
Sample Quantity:
AR No.:
TAD No/ Test Method Reference.:
S. No
Tests
Spec.
Results
Analyzed by:
Checked by:
Annexure – 6: Not provided here
Annexure – 7: Responsibility of QA Stability Coordinator
Receipt of Stability Sample from IPQA
Preparation of Stability Protocol
Loading of Sample in Stability Chamber
Make necessary entries in Stability Chamber Usage Log Book
Make necessary entries in Stability Study Schedule
Monitor Daily Environmental Condition (Temperature & Relative Humidity)
Withdrawal of Samples as per Stability Study Schedule
Preparation of Stability Analysis request and Report
Handover Stability Analysis request along with necessary samples to Analyst(s) for analysis
Receive and Review the Analytical Data
Prepare Summary Report
Annexure – 9 Stability Protocol Numbering Record
Sr. No.
Protocol No.
Product Name
Batch No.
Reason For Conducting Stability Study
Allotted by Date / Sign
Approved By (Head QA)
Annexure – 10: Stability Sample Destruction Record
Sr. No.
Product
Batch No.
Condition
Qty. To be Destroyed
Reason
Destroyed by / Date
Approved By / Date
Annexure – 11 Stability Study Sample
Pack Style :___________
Date :________________
Sign :________________
Annexure – 12: Intimation slip for Vendor change of API
Name of material:
Quantity Received:
Manufacturer:
Date of intimation:
Supplier:
From: RM Store
To: QA Department
Please note that above material is issued in following product first time.
Product name: _____________________________________________
Batch No.: _____________________________________________
Mfg. Date: _____________________________________________
Exp. Date: __________________________________ ________
Note: This is for your information and further action
Prepared By:
Received By:
Annexure 13 Stability study in case of container closure changes
|
Type of change |
Definition |
Examples |
Stability Data Package |
|
Changes that do not affect the protective properties
of the Container / closure system |
1.
Closure changes |
Adding
or changing a child-resistant feature to a packaging system or changing from
a metal to a plastic screw cap, while the inner seal remains unchanged. |
Type 0 |
|
2.
Changing the secondary packaging |
Changing
a carton. |
Type 0 |
|
|
3.
Removal of non-drug product material |
Removing: a. an
insert. b. a
filler. |
Type 0 Type 1 |
|
|
Changing the shape of container / closure |
(Without changing the size) |
Type 0 |
|
|
Changing the size of container / closure |
a. Within the approved range of size . b. Out side the approved range of size. |
Type 0 Type 2 |
|
|
Changes that may affect the protective properties of the container/closure system |
1. Adding or changing a component to increase protection within the same system. |
a. Adding, or changing to, a heat induction seal: b. Adding or changing a desiccant or filler. c.
Adding an over wrap or carton. |
Type 1 Type 2 Type 2 |
|
2. Changing the manufacturer or formulation of a container/closure component, including bottle or blister resin, cap liner, seal laminate, desiccant, filler, etc., within the same system. |
a.
Using an approved or compendium container or closure
equivalency protocol for: b.
Without an approved or compendium container or closure
equivalency protocol. |
Type 1 Type 2 |
|
|
3. Changing to a different container and closure system |
For any solid oral drug product. |
Type 3 |
Note: Type
0, Type 1, Type 2, Type 3 are data packages which is as per Annexure 14
Annexure 14 Stability Data Packages
|
Stability Data package |
Stability Data at the
time of regulatory submission |
Stability
Commitment |
|
Type 0 |
None |
None
beyond the Regular study |
|
Type 1 |
None |
First (1) production batch on long term condition. And Regular study. |
|
Type 2 |
3 months of comparative accelerated data and available long term
data on 1 batch with proposed changed. |
First (1) production batch on long term condition. And Regular study. |
|
Type 3 |
3 months of comparative accelerated data and available long term
data on 1 batch with proposed changed. |
First 3 production batch on long term condition. And Regular study. |
Regular
study – Any one of the first three batch of the year and any one of the first
three batch after every 100th batch in a year shall be
kept for long term stability study.
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