This document details the procedure for sample handling in the QC laboratory. It is the policy of XYZPharmaceuticals Limited that the written procedure shall be followed for the Sample handling.Â
This procedure is to be applied at the time of Sample
handling.
RESPONSIBILITYÂ & 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-Â 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. The 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, and damage
during transportation, and storage and handling of the test items.
5.1.10 The samples of the pharmaceutical products for tablets, Capsules, and raw
materials 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 a
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, or 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 The 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 is coded, and the code
number remains the same as long as the sample-related queries are made.
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 the 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 the 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.Â
5.1.28Â
Before taking the sample under the coding process, the sample is properly
checked for its requirements of fitness to be accepted.
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 are allocated a booking code, which is
used throughout the whole testing process for identification purposes. The
sample coding prevents the integrity and confidentiality of the sample.
5.1.37 The samples received are 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 A 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
7.0 Abbreviations
 P,
G: Plastic, Glass
G(A)
or P(A): Rinsed with 1 + 1HNO3
G(B):
Glass Borosilicate     Â
G(S):
Glass rinsed with an organic solvent
Refrigerate
Store at 4 deg. C ± 2 deg. C. `        Â
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:Â
Stands For Ayurvedic Finished Product
AR:Â
Stands For Ayurvedic Raw Material
FF:Â
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