Scribd
Upload
104 views

SOP-for-Sampling-of-Intermediate-Finished-Products

This Standard Operating Procedure (SOP) outlines the process for sampling intermediates and finished products within the Quality Assurance department. It details responsibilities, procedures for sample collection, and necessary precautions to ensure quality control. The document includes specific sampling plans for different product stages and references related forms and labels.

Uploaded by

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

SOP-for-Sampling-of-Intermediate-Finished-Products

This Standard Operating Procedure (SOP) outlines the process for sampling intermediates and finished products within the Quality Assurance department. It details responsibilities, procedures for sample collection, and necessary precautions to ensure quality control. The document includes specific sampling plans for different product stages and references related forms and labels.

Uploaded by

qaaudit
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 3

PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Sampling of Intermediates and Finished Products Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1.0 OBJECTIVE:
To lay down the procedure for sampling of intermediates and finished product dosage form.

2.0 SCOPE:
This SOP is applicable to the sampling of the intermediates and finished product samples for
in-process checks and final analysis of the product.

3.0 RESPONSIBILITY:
Production Officer and Quality Assurance officer.

4.0 DEFINITION(S):
NA

5.0 PROCEDURE:
5.1. On receipt of ‘’intimation for testing ‘’ slip (Refer Annexure-I) from production, QA shall
check that BMR is completed up to that stage.
5.2 QA shall prepare a ‘’sample for analysis’’ label as per Annexure-II.
5.3 Affix the label on the clean container to be used for sampling i.e. clean bottle or clean
polybag.
5.4 Ensure that sampling thief (if required) or that the sampling tools such as stainless steel spoons
and spatulas are cleaned before use.
5.5 Wear the latex hand gloves and mask.
5.6 Ensure that in-process container is affixed with label of correct product / batch number and
batch details.
5.7 Open the in-process containers and withdraw approximately equal quantity of sample from
each of the containers and collect in the clean polybags or bottles by using the cleaned
sampling devices as per sampling plan given below:
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Sampling of Intermediates and Finished Products Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
S.No. Stage Sampling plan
1. Blend/Granules Approximately 50 ml/50 g or as defined
in standardization or validation protocol
2. Core or Coated Tablets/ Approximately 50 tablets/ Capsules or as
Filled hard gelatin or soft defined in standardization or validation protocol
gelatin Capsules or as per finished product specification or
lot wise wherever required.
3. Finished Product As per finished product specification
(Tablets/Capsules)

4. Cleaning Validation As per Validation


Sample

5.8 Composite sample shall be prepared from the individual samples drawn from each
container by mixing homogeneously equal portions in a polybag from individual
samples.
5.9 In case of finished product, sample shall be collected form each individual container to
make a pool samples, quantity sufficient as specified in finished product specification.
5.10 Close the in process containers immediately.
5.11 Send the samples with ‘intimation for testing’ slip to Quality Control for analysis.
5.12 In case of Cleaning Validation, sample shall be collected form each individual
container quantity sufficient as specified in specification.

6.0 ABBREVIATION(S):
BMR : Batch Manufacturing Record
QA : Quality Assurance
QC : Quality Control

7.0 REFERENCE(S):
NA
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Sampling of Intermediates and Finished Products Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
8.0 ANNEXURE(S):
Annexure-I : ‘Intimation for Testing’ slip
Annexure-II: ‘Sample for analysis’ label
Annexure-II: Intimation for Cleaning Sample’ slip

9.0 REVISION CARD:


S.No. REVISION REVISION DETAILS OF REASON (S) FOR
No. DATE REVISION REVISION

You might also like