Standard Operating Procedure for Thawing of Raw Materials in pharmaceuticals

1. Purpose:

To lay down a procedure for thawing of Raw Materials in pharmaceuticals [company name].

2. Scope

The scope of this SOP is applicable for thawing of Raw Materials in pharmaceuticals [company name].

3. Responsibility

Warehouse personnel: Thawing the raw materials as per laid down procedure.

Head – warehouse: To ensure the compliance of SOP

4. Definitions

Thawing process means the frozen/ cold raw material container is placed into ambient conditions/ controlled room storage condition until fully liquefied or comes to the temperature of raw material to ambient temperature or temperature of required condition.

5. Procedure

Thawing of material is required in the condition where the material storage condition is less than the range of 15 to 30 °C (Controlled storage condition), example, 2-8 °C, -20 °C, -80 °C etc. and material to be processed at Controlled storage condition.
Material thawing will be required at the time of sampling and material dispensing for the batch. PPE shall be used while handling of material as recommended in the MSDS.
Ensure the storage conditions of the material as defined on manufacturer label.
Check the correct raw material code and A.R. number.
The time period required for thawing shall be as per the R&D recommendation. List of material thawing requirement shall be maintained.
Remove the material from cooling cabinet/ cold room and keep as per their thawing condition.
The thawing activity is to be carried out at recommended temperature and for recommended time as per approved list.
If required (as per the list), record the temperature of material before and after completion of thawing.
Ensure that as per the thawing is done as per defined period.
Ensure that thawing activity is completed before start of the sampling or dispensing activity. Once the sampling or dispensing is done, balance material shall be immediately transferred in to the storage area designated for the respective material as per their location.
Record door opening and door closing time in cooling cabinet/ cold room logbook as well as thawing activity log book after complete activity.
Ensure that the raw material status labeled for its status, i.e. quarantine or approved.
Ensure that material thawing should not be done more than recommended number of time mentioned by R&D and detailed in the list.

6. Frequency

During every sampling and dispensing of materials which required thawing as per the list.

7. Formats

7.1 Format for raw material thawing activity log book

Location :

Sr. No

Date

Material Name

Code No.

Control No.

Time of Thawing From

Time of Thawing To

Temperature of material before thawing

Temperature material after thawing

Appearance of material

Equipment No.

Checked By

Remark (if any)

7.2 Format for thawing requirements

Material name

Storage condition of material

Thawing condition

Time required for thawing

Temperature monitoring requirement after thawing (if any)

Number of maximum allowed thawing