Handling of Samples in Quality Control Laboratory :AN IDEAL PRACTICES

SAMPLING CONSIDERATION

Sending of Raw material, Packing material, In-process sample, Finished product and Stability Sample.

Sampling shall be done by IPQA personnel of concern Production area.

IPQA personnel of production area shall send the samples of Raw material, Packing material, In-process sample, Finished product and Stability Sample with ‘Test Request Form’.

Handling of Water Sample:

Sampling of water sample shall be done by Quality control Microbiology/ Quality control Chemical personnel.

Handling of Miscellaneous Sample:

Concern department shall send the Miscellaneous Sample with ‘Test Request Form’.

Note: Test Request Form should be in triplicate

Copy 1 For QC Chemical

Copy 2 For QC Microbiology

Copy 3 For QC Reference

RECEPIT ,REGISTRATION, ANALYSIS ,REVIEW OF REPORT AND DISPOSAL OF SAMPLE

Receipt and Registration of Samples

Quality control Section In-charge/Designee shall receive samples for analysis along with ‘Test Request Form’

Quality control Section In-charge/Designee shall check the sample label for correctness of information (Product Name, Batch Number or sampling point, etc) by comparing it against the ‘Test Request Form’. If any discrepancy is found, intimate to the  IPQA Designee for necessary corrective action.

Quality control Designee shall assign the A.R. number for Raw material, Packing material, In-process sample, finished product, Stability Sample samples and Miscellaneous Sample.

Ideal A.R. No for Raw material, Packing material, In-process sample, finished product, Stability Sample samples and Miscellaneous Sample shall be 9 digit and assign as per bellow :

CCYYXXXXX

Where,

CC stand for sample code as per Table 1

YY stand for last two digits of year, and

XXXXX stand for sequence number starting from 00001 for first sample received in calendar year. For next calendar year serial number again starts from 00001.

For example, first sample received in the year of 2016 shall be numbered as;

“ST1600001” for Stability Dapartment i.e : Table 1

Table 1

Sr. No.	Type of Sample	Code	Example of AR No. for first sample in current year(2016)
1.	Raw material,	RM	RM1600001
2.	Packing material	PM	PM1600001
3.	In-process sample	IP	IP1600001
4.	Finished product	FP	FP1600001
5.	Stability Sample.	ST	ST1600001
6.	Miscellaneous Sample	MS	MS1600001

In case of water samples QC microbiology shall allot the A. R. number.

Ideal unique numbering system for A.R. No.  of water sample shall be a assign  as per bellow :

DDMMYY/C

Where,

DD stand for date in two digits,

MM stands for month in two digits,

YY stand for last two digits of year, and

C stand for sampling point no of water sample.

Example: Sample of Purified water from sampling location PW-01 on date 01/06/16, A.R. No shall be assign as 010616/PW01

Received sample details and assign A.R. No shall be Recorded in LOG 1 (Specimen).

Note down the A.R. No. on the sample label as well as on the ‘Test Request Form’ in a legible manner.

Distribute the sample to QC Chemical and QC microbiology as per required test.

Store the samples at designated storage area in such a way that the samples are preserved to maintain integrity. The ‘Test Request Form’ document shall be filed in an easily retrievable manner.

Allocation of Sample

Based on work plan, the Team Leader shall allocate the samples on FIFO (first in first out) basis to Analyst who has been qualified and certified to perform those tests.

Sample allocation shall be Recorded in LOG 2(Specimen)

Analyst shall retrieve the sample from the storage area along with relevant documents (Test request form and Work Sheet) for analysis upon allocation.

Analysis

Analyst shall check whether the sample taken for analysis is in accordance with the ‘Test Request Form’ by comparing the A.R. No. Indicated on both.

Analyst shall take relevant Specification / Standard Test Procedure / Standard Operation procedure / General Testing Procedure by referring to the details (product name with strength, intended market / code number) given in the ‘Test Request Form’.

Analyst shall review the Work Sheets for correctness against the current Specification / Standard Test Procedure / Standard Operation procedure / General Testing Procedure.

The analysis of in-process samples of exhibit batches, pre-validation batches and validation batches, the sampling protocol / validation protocol shall be referred for the relevant Specification / STP number / SOP number / GTP number and acceptance criteria, wherever applicable.

If the sample is stored in polyethylene bags (self-sealed / heat sealed), then the Analyst shall place the original bag, after opening in another self-sealing poly ethylene bag, and thus preserve the sample throughout the analysis.

If the sample needs special care such as moisture prevention, light resistance, nitrogen atmosphere, then the same shall be maintained throughout the usage of the sample during the analysis.

Handle the samples carefully to avoid any microbial contamination using sterile poly bags.

Analyst shall organize required resources (Glassware, Media, culture, pipettes, Disinfectant, mopping duster etc.) in such a way that the analysis can be carried out in an efficient and sequential manner.

Analyst shall organize the work place in such a way that samples, Glassware, Media, culture, pipettes, Disinfectant, mopping duster are kept in a segregated and safe manner.

Analyst shall refer to the current version of relevant General Test Procedure (GTP) as mentioned in the individual STP / Specification for performing the analysis.

Analyst shall follow appropriate safety procedures as indicated in the general instructions, throughout the analysis.

Analyst shall check the validity of chemicals, reagents, media, and culture before using them for analysis. All invalid chemicals, reagents, indicators shall be discarded after crossing the labels.

Analyst shall bring to the attention of Team Leader if any abnormal observations or incidents during analysis and if any abnormality observe Analyst shall raise Deviation as per his respective procedure.

Analyst shall record and retain all results obtained during OOS investigation along with raw data duly identified for submissions for disposition of OOS investigation.

Analyst shall compile the report as soon as all tests are completed and shall arrange the Work sheets in the same sequence as in Test Request Form/ Work Sheets.

Analyst shall securely fasten the report along with all the raw data. The ‘Test Request Form’ shall be attached at the first sheet of the complete set of the report.

Report Review and Submission

After completion of analysis, Analyst shall handover the completed and signed document to Team leader for review.

Team leader shall review the Work Sheets and raw data for correctness of procedure, accuracy of data. Team leader shall ensure that traceability to relevant logs and indicate checked / reviewed by date and sign for each test as a proof of the review.

Team leader shall submit the reviewed and signed report to Laboratory Head or Designee for final conclusion (Approval/Rejection).

Team leader shall send the completed documents Document Cell or Quality Assurance as applicable.

Disposal of sample

Upon completion of the review of analytical report, the samples shall be disposed into respective containers meant for it.

Specimen Log

Reference:

Sr. No.	Title	Reference No.
1.	Sampling and testing of in-process materials and drug products	21 CFR Sec 211.110

Abbreviations:

Sr. No.	Abbreviation Used	Full Form of Abbreviation
1.	AR No.	Analytical Reference Number
2.	GTP	General Testing procedure
3.	No.	Number
4.	OOS	Out of specification
5.	OOT	Out of trend
6.	SOP	Standard Operating Procedure
7.	STP	Standard Test Procedure
8.	QA	Quality Assurance
9.	QC	Quality Control