1.0 OBJECTIVE
The objective of this policy document is to establish the ABC LABORATORIES PVT.Limited requirements and criteria for conducting stability studies, establishing shelf lives, determining appropriate storage and transportation conditions and assigning expiry dates for products under development as well as for routine production batches.
2.0 SCOPE
The scope of this policy is:
1. All bulk drugs products manufactured
3.0 DEFINITIONS
3.1 Stability Studies involve a series of tests conducted on active raw materials, their intermediates or finished dosage forms immediately following manufacture as well as after storage for se time periods under the influence of different environments factors
such as temperature, relative humidity, light, etc; these tests being designed to enable the establishment of an appropriate shelf life for a product and to determine appropriate storage and transportation conditions.
3.2 Shelf life is the period of useful life of a given active raw material, its intermediate or a given finished dosage form when kept under the recommended storage conditions, which have been established from stability studies and during which it can be guaranteed that the particular raw material or finished product will consistently meet its specifications. The specification at expiry of shelf life may be different to the release specification however, all differences must be justified.
3.3 Storage conditions are those conditions, based on the results of stability studies, under which it is recommended to store a given active raw material or its intermediate form, or a given finished dosage form throughout the duration of its shelf life so as to
guarantee the maintenance of the product quality, efficacy, safety and acceptability to the customer.
3.4 Transportation Conditions are those conditions, based on transportation and stability studies under which the product (intermediate, active raw material or finished dosage form) should be transported so as to guarantee the maintenance of product quality efficiency, safety and acceptability to the customer.
3.5 Expiry date is that date assigned to a given batch or lot of product to indicate the end of its useful shelf life.
4.0 DOCUMENTATION REQUIREMENTS
i) Stability Study Protocols
ii) Intermediate Stability Study Reports (i.e.,for products at clinical trial stage).
iii) Final Stability Study Report (i.e., report issued at the conclusion of a study).
Note: This should include a study summary with a critical synopsis of study aims, observations and conclusions, indicating storage conditions, proposed shelf life, shelf the specification, transport conditions as well as a statistical analysis of results.
3. Stability Review Form(SRF) – see example attached.
5.0 POLICY STATEMENTS
5.1 All label claims for ABC LABORATORIES PVT. Limited products are to be backed by appropriate stability study data for storage and transportation
5.2 Together with routine batch/lot analytical data, stability study data form the basis for the establishment of shelf-life specifications.
5.3 QA/QC department is responsible for all stability studies performed and stability study reports issued by personnel in its facilities .
5.4 The shelf life for a commercial product shall be based on real time stability study data, generated under the recommended storage conditions and in the packaging proposed for marketing.
5.5 Appropriately designed stability studies are to be initiated whenever the following occurs:
(a) a significant manufacturing process or synthesis change is made or planned to be made for a given bulk product
(b) a significant change in manufacturing equipment is made which could have an influence on product stability (e.g.blender).
(c) a significant process scale-up is made which could have an influence on product stability
(d) a switch is made to a new manufacturing site (e.g., with a Technology Transfer)
(e) a new source of a given bulk product is used.
(f) a batch of a given bulk product is due for inclusion in a routine annual stability verification program.
(g) regulatory agency requirements demand a particular stability study to be performed
(h) an evaluation is needed of the influence of storage during transportation on the stability of a given raw material or finished product.
5.6 New shelf lives for active raw materials, their intermediates, or finished products may be established and appropriate storage conditions determined internally in ABC LABORATORIES PVT. Limited via the Stability Review Form procedure (see paragraph 11 below), whenever intermediate or final stability study report are issued which can conclusively back up any label claims with respect to expiry dates and storage conditions.
5.7 It is however important to note that ABC LABORATORIES PVT. Limited Internally approved product shelf lives and storage
conditions must be approved by the Local Health Authority of individual countries before such information may be included on the printed packaging components of a particular product destined for a particular country for market or clinical trial purposes.
Note: If a large number of batches are produced each year (e.g. 20 or more batches), then 2(two) batches should be put up for annual stability study testing or stability verification.
5.8 A comprehensive list of ABC LABORATORIES PVT. Limited’s approved shelf lives and storage conditions will be maintained and periodically issued by the Head of Quality Assurance.
5.9 Thus the responsibility of the Head of Regulatory Affairs to confirm each health authority approval of the shelf life and storage conditions of each ABC LABORATORIES PVT. Limited product to the Head of Quality Assurance and the Technical Director.
6.0 STABILITY REVIEW FORM AND LIST : ANNEXURE-A
The following people have read this SOP and are currently following these procedures in the laboratory.
| Person | Signature | Date |
(PRODUCT STABILITY AND SHELF LIFE)
STABILITY REVIEW FORM (SRF)
SRF/QA/…/…
| Product Name (active raw material/or finished product): | |
| Product Status | |
| Number of Batches/Lots Studied:
|
|
| Storage Conditions During Study: | |
| Duration of Study: | |
| Transportation Studies Performed | |
| Attached Intermediate Stability Study Reports(s:
(e.g. for clinical trial material)
|
|
| Attached Final Stability Study Report(s); | |
| Proposed Shelf Life: | |
| Proposed Storage Conditions | |
| Proposal made by: Date: |
STABILITY REVIEW LIST
| DEPARTMENTY | COMMENTS | DATE & INITIALS |
| QC | ||
| QA |
REGULATORY LIMITATIONS
Notes:
(a) The registration of the ABC LABORATORIES PVT. Limited internally approved shelf life and storage conditions for a particular product with each local Health Authority needs to be pursued or a country by country basis.
(b) The registration status of the shelf life and storage conditions for a particular product should be verified by the Head of Regulatory Affairs on a country by country basis.
(c) It is important to note that the ABC LABORATORIES PVT. Limited internally approved shelf life and storage conditions for a particular product must be approved by each individual country’s local Health Authority before such information may be included on the printed packaging components of a particular product destined for a particular country for market or clinical trial purposes.