Standard Operating Procedure of Hold Time for Materials in Pharmaceuticals is describe in this post.
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1.
Purpose:
1.1. The
purpose of this document is to define the maximum hold time of materials in
quarantine and in-process product’s bulk.
2. Scope:
2.1. This
procedure is applicable to all starting materials and products being processed
at ALLMED Plant.
3. Responsibilities:
3.1. Q.A Manager
3.2. Q.A Officer
4. Procedure:
4.1. HOLD TIME OF STARTING MATERIALS IN QUARANTINE
|
S.
# |
Description
of Materials |
Maximum
Hold Time in Quarantine |
Storage
Conditions |
|
1 |
API |
5 working days |
As per relevant specifications |
|
2 |
Excipients |
7 working days |
As per relevant
specifications |
|
3 |
Packing Materials |
7 working days |
As per relevant
specifications |
|
4 |
Dispensed Raw Material |
2 working days |
As per relevant
specifications |
4.2. HOLD TIME OF BULK PRODUCTS IN PRODUCTION AREA
|
S. # |
Description of Products |
Maximum Hold Time in Quarantine |
Storage Conditions |
|
1 |
Grains of OSD Products |
3 days |
As per relevant specifications |
|
2 |
Core Tablets |
7 days |
As per relevant specifications |
|
3 |
Coated Tablets |
7 days |
As per relevant specifications |
|
S. # |
Description of Products |
Maximum Hold Time in Quarantine |
Storage Conditions |
|
4 |
Blisters of Tablets & Capsules |
30 days |
As per relevant specifications |
|
5 |
Moisture Sensitive Grains/ Tablets |
24 hrs. |
As per relevant specifications |
|
6 |
Filled Capsules |
7 days |
As per relevant specifications |
|
7 |
Bulk of Liquid Syrup |
2 days |
As per relevant specifications |
|
8 |
Filled & Sealed Bottles of Liquid Syrup |
30 days |
As per relevant specifications |
|
9 |
Bulk Solutions of Sterile Products |
12 hrs. |
As per relevant specifications |
|
10 |
Sterilized Filled & Sealed Ampoules and Vials |
30 days |
As per relevant specifications |
4.3 This hold time is
tentative and valid till evaluation / study / of hold time of individual
products.
4.4 QA after evaluation
/ determination of hold time of individual product will issue the hold time of
that product accordingly.
4.5 In case of deviation
of valid hold time QA will issue deviation report / NCR to investigate the
reason of deviation.
4.6 In case of deviation
of valid hold time, product will be retested before next process and such activity
will be documented by QA and will also be part of BMR.