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Hold Time for Materials in Pharmaceuticals

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.

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