SOP for Sample Handling in Laboratory | Specimen Collection Procedure

This document details the procedure for the sample handling in the qc laboratory. It is the policy of XYZPharmaceuticals Limited that the written procedure shall be followed for the Sample handling

This procedure is to be applied at the time of Sample handling.

RESPONSIBILITY & ACCOUNTABILITY

Persons along with their responsibilities and accountability are given below:

Executive - Corporate Quality Assurance: - To prepare SOP and follow the same

Trainee Analyst / Jr. Analyst / Analyst / Sr. Analyst:- To follow the SOP accordingly

Manager – Quality Assurance/ Section– In Charge/ Manager-Quality Assurance/ Manager –Technical/ Assistant General Manager- Corporate/ Quality Manager:- To ensure implementation of SOP

5.0 PROCEDURE

5.1 Handling of the Samples

5.1.1 The sample received by the laboratory is handled very carefully and systematically.

5.1.2 The sample provided by the client for the analysis, is first of all verified for the testing parameters and the facility available with the laboratory to analyze the sample to meet the requirement.

5.1.3 If the facility exists for testing the sample provided by the client. Laboratory clarifies the charges of testing to the client.

5.1.4 On request of the client the sample is forwarded to the sample booking section.

5.1.5 The sample is booked for the parameters as requested by the client.

5.1.6 A copy of the booking slip is issued to the client and the original is kept with the booking section in -charge.

5.1.7 The booking slip contains the details of the client’s address, contact number and the number of the test parameters.

5.1.8 The sample is coded by the sample booking in charge.

5.1.9 The sample is handled with great care to avoid deterioration, Loss, damage during transportation, and storage and handling of the test items.

5.1.10 The samples of the pharmaceuticals products for tablets, Capsules, and raw material are properly packed.

5.1.11 The samples are less volume-occupying in nature, which can accommodate in small space. The laboratory representative (marketing Executive) is provided with the briefcase of hard material (Polymer) to protect the compression of the sample (spoilage of the sample), which does not allow the sample to deteriorate, damage, and loss due to compression from an outside force.

5.1.12 similarly the bottles of suspension and the ointments are kept inside the case and properly separated by either cardboard packing or by the foam separator or by the means of cotton separators as applicable.

5.1.13 Laboratory has the arrangement to store the sample at the desirable environmental conditions. Such types of samples are stored or conditioned before the start of the sample. The integrity of the sample is protected by marking it properly and by providing the proper *code number to it.

5.1.14 Laboratory has a procedure to identify the sample or test items. The system remains the same throughout the life of the product or test item in the laboratory.

5.1.15 The sample after receiving in the sample booking section are coded, the code number remains the same as long as the sample-related queries are mad.

The coding of the sample or test items is done as follows-

Sample Group / Year / Month / Date / Sr. No.

For Example DF/05/03/16/30

5.1.16 The material is identified by the group/category of the product.

5.1.17 The sample undergoes the booking process & coded as an above system.

5.1.18 The type of sample belonging to the particular group or category is properly identified and placed at the first position of the coding system.

5.1.19 The sample-booking year is placed at the second position of the coding system.

5.1.20 The sample-booking month is placed at the third position of the coding system.

5.1.21 The sample-booking date is placed at the fourth position of the coding system.

5.1.22 The sample –booking a serial number of the day for that particular group or category is placed at the fifth place of the coding system.

5.1.23 The coding system once given to the particular sample is known by that number till the sample is remaining in the laboratory or for any query of the sample.

5.1.24 The laboratory personnel in the laboratory know the sample by the sample coding system.

5.1.25 The client is not allowed to know the sample code number till the report is dispatched to the client. In case of any query regarding his sample, he shall be connected to the authorized person dealing with the clients. The dealing person knows the sample by the description of the client's address and contact number. The address and contact number of the client are kept at the sample booking counter.

5.1.26 The sample inside analytical premises is known by the name of the coding system.

5.1.27 The confidentiality of the client is maintained by this system. Neither the client knows about the sample code nor does the analyst know the client's name and contact number from this coding system. 

5.1.28  Before taking the sample under the coding process, the sample is properly checked for its requirements of fitness to accept.

5.1.29 The quantity of the sample is checked.

5.1.30 The number of parameters to be carried out is checked.

5.1.31 The test method or test protocol provided/specified by the client is checked.

5.1.32 Any deterioration due to transportation or handling is properly checked in the sample.

5.1.33 Any loss or damage observed to the sample due to the handling of the sample.

5.1.34 Any abnormality in the shape of the sample if for physical analysis is properly checked.

5.1.35 If any of the above is found not satisfying the requirement, the client is immediately informed of the matter either telephonically, through e-mail, or personally if local and possible to contact him. After getting clarification from the client, the sample is allowed for the processing of the coding system.

5.1.36 The samples received for testing after ascertaining their test requirements, facilities available, and testing charges is allocated a booking code, which is used throughout the whole testing process for identification purpose. The sample coding prevents the integrity and confidentiality of the sample.

5.1.37 The samples received is verified for the following details:

5.1.37.1 Name of the party

5.1.37.2 Postal address

5.1.37.3 Telephone/Fax No.

5.1.37.4 Contact person

5.1.37.5 Sample description and B. No./Code No., Date of Mfg./Exp/Best Before, if any.

5.1.37.6 Tests required

5.1.37.7 Date of receipt

5.1.37.8 Job No./Code No. Assigned to the sample

5.1.38 The documented samples are sent to the Analytical Division where they are assigned to the respective analyst, along with datasheets/records of analysis.

5.1.39 All care is taken during the transit to prevent the samples from any deterioration,  damage or loss. Quantity of the sample

5.1.40 Adequate precautions and care are undertaken to safeguard the samples from any damage and deterioration, during storage and testing in the laboratory.

5.1.41 Perishable nature of samples is sent to the testing laboratory immediately and undertaken for testing.

5.1.42 Sample requiring refrigeration is preserved in the refrigerator as and when received in the laboratory.

5.1.43 Samples, where a stability study, other than chemical analysis is required, are preserved in a separate sealed container.

5.1.44 Samples where microbiological testing other than chemical tests are also required to be carried out, it is desired to have it in separate containers to avoid any external contamination.

5.1.45 It is advised to procure the samples for microbiological testing in separate sterilized glass bottles supplied by the organization.

5.1.46 In the case of Retesting of microbiological Samples, it is done only on fresh Samples by spiking the sample.

5.1.47 The samples during the testing period remain in the custody of the concerned analyst.

5.1.48 The analyst takes care of the sample during the analysis. After the samples have been tested, they are marked with a date of reporting and stored in the storage cupboards with the date of disposal.

5.1.49 The perishable samples are destroyed immediately after issuing a test report.

5.1.50 The non-perishable samples are retained for a period of 30 days from the date of issue of the test report.

5.1.51 The sample is returned to the party if requested by the client/party at the time of booking the sample.

5.1.52 The samples are disposed of under the supervision of the Quality Manager/Technical Manager/ Section In Charge/ Store Keeper

6.0 METHOD OF WATER SAMPLING AND HANDLING

6.1 The sampling of water is carried out for chemical/physical and microbiological testing.

6.2 The sampling of water analysis is carried out for its physical and chemical analysis.  The sampling guidelines are taken from the APHA (American Public Health Association) and Indian Standard Specifications

6.3 The water sample is preserved as the parameters tabulated below.

PRESERVATION OF WATER SAMPLE PARAMETERS

PRESERVATION OF WATER SAMPLE PARAMETERS

7.0 Abbreviations

 P, G: Plastic, Glass

G(A) or P(A): Rinsed with 1 + 1HNO3

G(B): Glass Borosilicate      

G(S): Glass rinsed with an organic solvent

Refrigerate Store at 4 deg. C ± 2 deg. C. `         

Analyze immediately: analyze within 15 minutes of sample collection

N.S. : Not stated in the cited reference

PTFE: Polytetrafluoroethylene

DF: Stands For Drug Finished Product

DR: Stands For Drug Raw Material

NF: Stands For Non-Drug Finished Product

NR: Stands For Non-Drug Raw Material

AF:  Stands For Ayurvedic Finished Product

AR:  Stands For Ayurvedic Raw Material

FF:  Stands For Food Finished Product

FR: Stands For Food Raw Material

CF: Stands For Cosmetic Finished Product

CR: Stands For Cosmetic Raw Material

BM: Building Material

XYZ: XYZ Pharmaceuticals Limited

CQA: Corporate Quality Assurance

SOP: Standard Operating Procedure

* Where ever applicable

>Standard Operating Procedures for the Laboratory safety


>Good documentation Practices in pharma

BANTI SINGH

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