3.0 Sop of Sample Handling Auriga Research LTD Baddi

Code : ARLB/QC/SOP-0 03
AURIGA RESEARCH LIMITED Issue No. : 01

Eff. Date 12-Apr-2009
DC Complex Village-Bagbania Tehsil- Nalagarh
Solan-Himachal Pradesh
STANDARD OPERATING PROCEDURE
TITLE: HANDLING OF SAMPLE
OWNER (S): SECTION IN CHARGE
DOCUMENT APPROVAL
Authority Name Job Title Signature Date

Author Vijay Kumar Analyst
Process Owner Rakesh Sharma Section In charge
Technical Approver Pankaj Tyagi Person In charge
DOCUMENT DISTRIBUTION
COPY NO. COPY HOLDER
1 Section In Charge
2 QA Manager
Filename: ARLB_QC_SOP_003 issue01 Page 1 of 14
COMPANY CONFIDENTIAL
Uncontrolled Copy if QA Stamp is not Red
HANDLING OF SAMPLE
CONTENTS
0.0 VERSION CONTROL HISTORY----------------------------------------------------------------------------- 2

1.0 WHAT----------------------------------------------------------------------------------------------------------------3
2.0 WHY----------------------------------------------------------------------------------------------------------------- 3
3.0 WHEN--------------------------------------------------------------------------------------------------------------- 3
4.0 RESPONSIBILITY----------------------------------------------------------------------------------------------- 3
5.0 PROCEDURE----------------------------------------------------------------------------------------------------- 4
5.1 HANDLING OF THE SAMPLES------------------------------------------------------------------------------ 4
6.0 ANALYTICAL REPORT / YEAR / MONTH / DATE / SERIAL NUMBER---------------------------5
6.1 ABBREVIATION FOR SAMPLE GROUP:------------------------------------------------------------------5
7.0 METHOD OF WATER SAMPLING AND HANDLING ---------------------------------------------------9
8.0 PRESERVATION OF WATER SAMPLE PARAMETERS---------------------------------------------10
9.0 ABEREVIATION----------------------------------------------------------------------------------------11
10.0 REFERENCE------------------------------------------------------------------------------------------------------11
11.0 APPENDIX I SAMPLE ENTRY RECORD----------------------------------------------------------------12
12.0 APPENDIX II SAMPLE COADING RECORD-------------------------------------------------------------13
13.0 APPENDIX III SAMPLE DISTRIBUTION AND WORK SHEET RECEIVING RECORD-------14
14.0 APPENDIX IV HOLD SAMPLE RECORD-----------------------------------------------------------------15
0.0 VERSION CONTROL HISTORY
Date Issue No. CCR Change description / reason / supersedes

12-APR-09 01 Nil New document.
HANDLING OF SAMPLE
1.0 WHAT
This document details the procedure for the handling of sample
2.0 WHY
It is the policy of Auriga Research Limited that the written procedure will be followed for the
handling of sample and its use monitored in order to ensure that the operation is carried
uniformly by any of the analyst so as to avoid any deviation from the procedure.
3.0 WHEN
This procedure is to be applied at the time of handling of sample
4.0 RESPONSIBILITY
Persons along with their responsibilities are given below:
S. No Designation Responsibility
01 Analyst To prepare the SOP and follow the SOP.

02 Section In Charge To ensure implementation of SOP.
03 Quality Assurance Incharge To ensure implementation of SOP
HANDLING OF SAMPLE
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 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 If facilities available out of order due to some reason sample goes for hold.
5.1.9 The sample is coded by the sample booking in-charge in coding/de coding room for
confidential coding.
5.1.10 The sample is handled with great care to avoid it deterioration, Loss, damage during
transportation, and storage and handling of the test items.
5.1.11 The samples of the pharmaceuticals products and raw material are properly packed.
5.1.12 The samples are less volume occupying in nature, which can accommodate in small space.
5.1.13 The laboratory representative (marketing Executive) is provided with the brief case 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 out side
force.
5.1.14 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.
5.1.15 Laboratory has arrangement to store the sample at the desirable environmental conditions.
Such type of sample are stored or conditioned before the start of the sample. The integrity of
the sample is protected by marking it properly and by providing proper *code number to it.
HANDLING OF SAMPLE
5.1.16 Laboratory has 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.
5.1.17 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 following-
6.0 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 following-
SAMPLE GROUP / YEAR / MONTH / DATE / SR. NO.
For Example: ARLB/DF/090412001
ABBREVIATION FOR SAMPLE GROUP:
ARLB : AURIGA RESEARCH LIMITED BADDI
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
FF : Stands For Food Finished Product
FR : Stands For Food Raw Material
CF : Stands For Cosmetic Finished Product
CR : Stands For Cosmetic Raw Material
* Where ever applicable
HANDLING OF SAMPLE
6.1 ABBREVIATION FOR SAMPLE GROUP:
6.1.1 The material is identified by the group / category of the product.
6.1.2 The sample undergoes booking process & coded as above system.
6.1.3 The type of the sample belonging to the particular group or category is properly Identified and
placed at the first position of the coding system.
6.1.4 The sample-booking year is placed at the second position of the coding system.
6.1.5 The sample-booking month is placed at the third position of the coding system.
6.1.6 The sample-booking date is placed at the fourth position of the coding system.
6.1.7 The sample –booking serial number of the day for that particular group or category is placed at
the fifth place of the coding system.
6.1.8 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.
6..1.9 The laboratory personnel in the laboratory know the sample by the sample coding system.
6.1.10 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 address and contact number. The address and contact number of the client are kept at
the sample booking counter.
6.1.11 The sample inside analytical premises in known by the name of the coding system.
6.1.12 The confidentiality of the client is maintained by this system. Neither the client knows
about the sample code nor does the analyst know the clients name and contact number from
this coding system.
6.1.13 Before taking the sample under coding process, the sample is properly checked for its
requirements of fitness to accept.
6.1.14 The quantity of the sample is checked.
6.1.15 The number of parameters to be carried out is checked.
6.1.16 The test method or test protocol provided / specified by the client is checked.
6.1.17 Any deterioration due to transportation or handling is properly checked in the sample.
6.1.18 Any loss or damage observed to the sample due to the handling of sample.
6.1.19 Any abnormality in the shape of the sample if for physical analysis is properly checked.
HANDLING OF SAMPLE
6.1.20 If any of the above is found not satisfying the requirement, the client is immediately informed
of the matter either by 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.
6.1.21 The samples received for testing after ascertaining its 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.
61.22 The samples received are verified for the following details:
6.1.23 Name of the party
6.1.24 Postal address
6.1.25 Telephone/Fax No.
6.1.26 Contact person
6.1.27 Sample description and B. No./Code No., Date of Mfg./Exp/Best Before, if any.
6.1.28 Tests required
6.1.29 Date of receipt
6.1.30 Job No./Code No. Assigned to the sample
6.1.31 The documented samples are sent to the Analytical Division where they are assigned to the
respective analyst, along with data sheets / record of analysis.
6.1.32 All care is taken during the transit to prevent the samples from any deterioration, damage or
loss. Quantity of the sample
6.1.33 Adequate precautions and care is undertaken to safeguard the samples from any damage
and deterioration, during storage and testing in the laboratory.
6.1.34 Perishable nature of samples are sent to the testing laboratory immediately and undertaken
for testing.
6.1.35 Sample requiring refrigeration is preserved in the refrigerator as and when received in the
laboratory.
6.1.36 Samples where a stability study, other than chemical analysis is required are preserved in a
separate sealed container.
6.1.37 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.
6.1.38 It is advised to procure the samples for microbiological testing in separate sterilized glass
bottles supplied by the organization.
HANDLING OF SAMPLE
6.1.39 In case of Retesting of microbiological Sample, it is done only on fresh Sample by spiking the
sample.
6.1.40 The samples during the testing period remain in the custody of the concerned analyst.
6.1.41 The analyst takes care of the sample during the analysis. After the samples have been tested,
they are marked with date of reporting and stored in the storage cupboards with the date of
disposal.
6.1.42 The perishable samples are destroyed immediately after issue of test report.
6.1.43 The non-perishable samples are retained for a period of 30 days from the date of issue of the
test report.
6.1.44 The sample is returned to the party, if requested by the client / party at the time of booking
sample.
6.1.45 The samples are disposed off under the supervision of the Quality Manager/Technical
Manager/ Section In Charge/ Store Keeper
6.1.46 After Analysis of Sample worksheet prepared by Analyst and worksheet record returned in
Coding room / Distribution room for decoding.
6.1.47 On the base of Date of Complete Analysis report Number will generate procedure are as
following.
6.1.48 First write Group Second Year Third Month Fourth Date Fifth Work order in three digit e.g.
ARLB/DR/090412/001
7.0 METHOD OF WATER SAMPLING AND HANDLING
7.1 The sampling of water is carried out for chemical / physical and microbiological testing.
Sampling of water for microbiological testing is carried out as per Standard Operating
Procedure ARLB/MC/SOP-023, Microbiological sampling handling & storage.
7.2 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
7.3 The water sample is preserved as the parameters tabulated below.
HANDLING OF SAMPLE
8.0 PRESERVATION OF WATER SAMPLE PARAMETERS
Sr. Parameters Container Preservation Maximum

No. Type Storage Time
1 Acidity P, G (B) Refrigerator 24 h
2 Alkalinity P, G Refrigerator 24 h
3 BOD P, G Refrigerator 6h
4 Boron P (PTFE) or HNO3 to pH <2 28d
Quartz
5 Bromide P, G None required 28 d
6 Carbon, Organic, Total G, (B) Analyse Immediately or Refrigerate 7d
and add HCL, H3PO4 to pH <2
7 Carbon Dioxide P, G Analyse Immediately 0.25 h
8 Chloride P, G None Required N.S.
9 Chlorine, Total, P,G, Analyse immediately 0.25 h
Residual
10 Colour P, G Refrigerator 48 h
11 Cyanide P, G Refrigerator 28 d
12 Fluoride P None Required 28 d
13 Hardness P,G Add HNO3 or H2SO4 to pH <2 6 month
14 Metals, general P(A), G(A) For dissolve metals filter immediately, 6 month
add HNO3 to pH <2
15 Chromium VI P (A), G(A) Refrigerator 24 h
16 Copper by Colorimetry P (A), G(A) Refrigerator 24 h
17 Ammonia P, G Analyse as soon as possible, add 7d
H2SO4 to pH <
18 Nitrate P, G Analyse as soon as possible (Refrig.) 48 h
HANDLING OF SAMPLE
19 Nitrite P, G Analyse as soon as possible 48 h

Refrigerator
20 Nitrate + Nitrite P, G Add H2SO4 to pH<2, Refrigerator 1-2 d
21 Organic Kjeldahl P, G Refrigerator, add H2SO4 to pH <2 7d
22 Odor G Analyse as soon as possible 6h
Refrigerator
23 Oil & grease G Add HCl or H2SO4 to pH <2, 28 d
Refrigerator
24 Pesticides G (S), Refrigerate, add 1000 mg ascorbic 7d
PTFR-lined acid / L if residual chlorine present.
cap
25 Phenol P, G, PTFE- Refrigerate, add H2SO4 to pH <2 -
lined cap
26 Dissolve Oxygen G, BOD Analyse immediately 0.25 h
Bottle
27 pH P, G Analyse Immediately 0.25 h
28 Salinity G, Wax seal Analyse immediately or use wax seal 6 month
29 Total Phosphorus P, G Add H2SO4 to pH <2 and refrigerate 28 d

30 Silica P, PTFE or Refrigerate, do not freeze 28 d
Quartz
31 Sulphate P, G Refrigerate 28 d
32 Sulphide P, G Refrigerate, Add 4 drops 2N Zinc 28 d

Acetate / 100 ml, add NaOH to pH >9
33 Temperature P, G Analyse immediately 0.25 h
34 Turbidity P, G Analyse same day; store in dark up to 24 h
24 h, refrigerate
9.0 ABBREVIATIONS:-
HANDLING OF SAMPLE
P, G : Plastic, Glass
G(A) or P(A) : Rinsed with distilled water 1 : 1HNO3 (Nitric acid )
G(B) : Glass Borosilicate
G(S) : Glass rinsed with organic solvent
Refrigerate : Store at 4O± 20C.
Analyse immediately : analyse within 15 minutes of sample collection
N.S. : Not stated in cited reference
PTFE : Poly tetra fluoro ethylene
H2SO4 : Sulfuric acid
H3PO4 : Phosphoric Acid
HCl : Hydrochloric Acid
NaOH : Sodium Hydroxide
ARLB : Auriga Research Ltd Baddi
QC : Quality Control
SOP : Standard Operating Procedure
CCR : Change Control Reference Number
10.0 REFERENCE:- Nil.
RECORD THE DATA ON APPENDIX I FORMAT NO. ARLB / QC/SOP-003/FR-01

HANDLING OF SAMPLE
11.0 APPENDIX I ARLB / QC/SOP-003/FR-01
SAMPLE ENTRY RECORD
Location : Reception
S. Sample Name Batch No. Test Require Submitt Party Name Mfg. Date Exp. Date Sample AR Dispatch Date Invoice Remarks
No. ed By. / Manufacturer Qty. No. of Report/sign
Name
HANDLING OF SAMPLE
12.0 APPENDIX II ARLB / QC/SOP-003/FR-02
SAMPLE COADING RECORD
Location : Sample coding Room / Room No-17
S. No. Batch Submitted by Manufactured by Code Date of Remarks

Number number Coding
13.0 APPENDIX III ARLB / QC/SOP-003/FR-03
SAMPLE DISTRIBUTING AND WORK SHEET RECEIVING RECORD
S. No. Code Test Issued Issued Date of Date of AR Number Remarks

Numb Parameter by To Issue completed
er Analysis
HANDLING OF SAMPLE
14.0 APPENDIX IV ARLB / QC/SOP-003/FR-04
HOLD SAMPLE RECORD
S. No. Sample Batch Mfg. Exp. Sample Submitted Party Reason for Hold Remarks
Name No. Date Date Qty. By. Name / Sample
Manufactu
rer Name

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Code : ARLB/QC/SOP-0 03

AURIGA RESEARCH LIMITED Issue No. : 01

STANDARD OPERATING PROCEDURE

TITLE: HANDLING OF SAMPLE

OWNER (S): SECTION IN CHARGE

Authority Name Job Title Signature Date

Process Owner Rakesh Sharma Section In charge

Technical Approver Pankaj Tyagi Person In charge

COPY NO. COPY HOLDER

Filename: ARLB_QC_SOP_003 issue01 Page 1 of 14

0.0 VERSION CONTROL HISTORY----------------------------------------------------------------------------- 2

0.0 VERSION CONTROL HISTORY

Date Issue No. CCR Change description / reason / supersedes

Filename: ARLB_QC_SOP_003 issue01 Page 2 of 14

01 Analyst To prepare the SOP and follow the SOP.

Filename: ARLB_QC_SOP_003 issue01 Page 3 of 14

5.1 HANDLING OF THE SAMPLES

Filename: ARLB_QC_SOP_003 issue01 Page 4 of 14

SAMPLE GROUP / YEAR / MONTH / DATE / SR. NO.

For Example: ARLB/DF/090412001

ABBREVIATION FOR SAMPLE GROUP:

ARLB : AURIGA RESEARCH LIMITED BADDI

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

FF : Stands For Food Finished Product

FR : Stands For Food Raw Material

CF : Stands For Cosmetic Finished Product

CR : Stands For Cosmetic Raw Material

* Where ever applicable

Filename: ARLB_QC_SOP_003 issue01 Page 5 of 14

6.1 ABBREVIATION FOR SAMPLE GROUP:

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

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

Filename: ARLB_QC_SOP_003 issue01 Page 6 of 14

Filename: ARLB_QC_SOP_003 issue01 Page 7 of 14

7.0 METHOD OF WATER SAMPLING AND HANDLING

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

Filename: ARLB_QC_SOP_003 issue01 Page 8 of 14

8.0 PRESERVATION OF WATER SAMPLE PARAMETERS

Sr. Parameters Container Preservation Maximum

Filename: ARLB_QC_SOP_003 issue01 Page 9 of 14

19 Nitrite P, G Analyse as soon as possible 48 h

29 Total Phosphorus P, G Add H2SO4 to pH <2 and refrigerate 28 d

32 Sulphide P, G Refrigerate, Add 4 drops 2N Zinc 28 d

Filename: ARLB_QC_SOP_003 issue01 Page 10 of 14

10.0 REFERENCE:- Nil.

RECORD THE DATA ON APPENDIX I FORMAT NO. ARLB / QC/SOP-003/FR-01

Filename: ARLB_QC_SOP_003 issue01 Page 11 of 14

11.0 APPENDIX I ARLB / QC/SOP-003/FR-01

SAMPLE ENTRY RECORD

Filename: ARLB_QC_SOP_003 issue01 Page 12 of 14

12.0 APPENDIX II ARLB / QC/SOP-003/FR-02

SAMPLE COADING RECORD

Location : Sample coding Room / Room No-17

S. No. Batch Submitted by Manufactured by Code Date of Remarks

13.0 APPENDIX III ARLB / QC/SOP-003/FR-03

SAMPLE DISTRIBUTING AND WORK SHEET RECEIVING RECORD

Location : Sample coding Room / Room No-17

S. No. Code Test Issued Issued Date of Date of AR Number Remarks

Filename: ARLB_QC_SOP_003 issue01 Page 13 of 14

14.0 APPENDIX IV ARLB / QC/SOP-003/FR-04