Scribd
Upload
48 views4 pages

SOP For Stability Testing Program

Uploaded by

anjumpq
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
48 views4 pages

SOP For Stability Testing Program

Uploaded by

anjumpq
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 4

BIO CLASSIC PHARMA

Title: STABILITY TESTING PROGRAM

Department: Q.C Revision #:01 EffectiveDate:12-10-2023 Review Date: 12-10-2026

Doc. No.: BCP/SOP/04-011 Issued Date: 12-10-2023 Page 1 of 4

AMENDMENT STATUS
Date of Issue Page Page
Sr.# Details of change / review
Amendment Status No Status
1
2
3
4
5

Prepared by Checked by Approved by

____________ ___________ ______________


QC Officer QC Manager QA Manager
BIO CLASSIC PHARMA
Title: STABILITY TESTING PROGRAM

Department: Q.C Revision #:01 EffectiveDate:12-10-2023 Review Date: 12-10-2026

Doc. No.: BCP/SOP/04-011 Issued Date: 12-10-2023 Page 2 of 4

1. Purpose
1.1 To establish a standard operating procedure for Stability Testing Program.
2. Scope
2.1 This Procedure is applicable for Stability Testing Program.
3. Responsibility:-

 Quality Control Manager


 Quality Control Officer
4. Procedure:-
Methodology
Pharmaceutical products manufactured at Lab are tested at designated intervals for certain chemical,
physical, and microbiological (where applicable) properties, to confirm the stability of the product
and compatibility with its immediate container, while stored in accordance with labeled conditions
and time, particularly with respect to product degradation.

The number of batches, the condition and time intervals will depend on the type of products
involved.

 Stability programme at Labs includes:


a) Stability of New Products
b) Stability of currently marketed products (on going stability)
c) Stability of currently marketed products with significant change in formula, process, packaging or
material source.

 The stability of the product is determined by validated analytical methods


 When a stability profile illustrates little or no change, the frequency of performing each test may
be reduced, but physical inspection must be performed at each testing period.

 Product characteristics during stability may be different than those at the time of release.
 Stability testing programmes must ensure that products meet required specifications throughout
their shelf life.

 Normally for stability testing, only ambient storage conditions, or conditions consistent with
product labeling, are required. Only for special cases accelerated conditions will be required.

Prepared by Checked by Approved by

____________ ___________ ______________


QC Officer QC Manager QA Manager
BIO CLASSIC PHARMA
Title: STABILITY TESTING PROGRAM

Department: Q.C Revision #:01 EffectiveDate:12-10-2023 Review Date: 12-10-2026

Doc. No.: BCP/SOP/04-011 Issued Date: 12-10-2023 Page 3 of 4

5. Product Stability Sample / Test Frequency

Product Climatic Condition Product Shelf Test Frequency


Categories Life (Months)
(Months)
New Products & A) Accelerated condition Samples of three batches at 0, 1, 3
current products months
o
with CHANGE in i) 40 C & R.H. < 40%
formula, process, ii) 40 o C & 75 % R.H.
packaging or iii) Ambient Temp. (15 – 30 o C)
source of material B) Ambient Temp (15 – 30 o C) 12 --------- 24 Two batches of each dosage form and
30 --------- 36 one batch significantly different
48 Months packaging
60 Months 0,3,6,9,12, Exp. Date
0,3,6,9,12,18,24, Exp Date
0,3,6,9,12,18,24,36, Exp. Date
0,3,6,9,12,18,24,36,48, Exp. Date
Currently Ambient Temp. (15 – 30 o C) 12 --------- 24 One batch per year as for each
marketed products 30 --------- 36 product & different dose (250, 500
(ongoing stability) 48 Months mg etc) and different packaging (e.g.
60 Months Blister, Glass, Bottle)
0,6,12, Exp. Date
0,6,12,24, Exp. Date
0,6,12,24,36, Exp Date
0,6,12,24,36,48, Exp Date

A decision to forego testing of the revised formulation, process, package, or use of a new supplier, can be made
by QC Manager at the manufacturing plant based on the technical assessment of the significance of the
change and historic stability and the profile of the product.

Prepared by Checked by Approved by

____________ ___________ ______________


QC Officer QC Manager QA Manager
BIO CLASSIC PHARMA
Title: STABILITY TESTING PROGRAM

Department: Q.C Revision #:01 EffectiveDate:12-10-2023 Review Date: 12-10-2026

Doc. No.: BCP/SOP/04-011 Issued Date: 12-10-2023 Page 4 of 4

QC Manager ensures that the change to forego is indeed a minor change & decision to forego testing is
documented and reported.
6. Data Review and Reporting
The Quality Control Manager is responsible for review of all stability data, data analysis &
maintaining all stability records.
7. Equipment:-
Stability study is conducted in stability chamber equipped with ultrasonic humidifier for relative
humidity condition and chamber light.
8. Precautions:-
 Ensure humidifier is filled with water before start.
 Switch off stability chamber after 180 hours continuous run then restart 30 minutes after switch off.
 Adjust correct Temp / R. humidity from front panel.

Prepared by Checked by Approved by

____________ ___________ ______________


QC Officer QC Manager QA Manager

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy