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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