Standard test procedure in pharmaceuticals
Purpose
This SOP describes the procedure for Preparation of
Specifications & Standard Test Procedure of Raw Materials, Packing
Materials, In-Process, finished product and General Test Procedure for Analytical
Solution.
Procedure:
All Active Raw Materials and Excipients Raw Materials Specification
& STP (Standard Test Procedure) shall be prepared.
Specification, STP No. & Material name shall be
listed accordingly with respect to the title name.
All Finished Product and In-process specification &
STP shall be prepared.
Specification, STP No. & Product Name shall be
listed accordingly with respect to the title name.
All Packing Materials specification shall be prepared.
Specification & Material Name shall be listed
accordingly with respect to the title name.
All Packing Materials GTP (General test procedure)
shall be prepared.
STP No. & Material Name shall be listed accordingly
with respect to the title name.
All Analytical Solution GTP shall be prepared.
STP No. & Analytical Solution shall be listed
accordingly with respect to the title name.
Analytical Research development shall prepare the
Specification, STP and GTP for Formulation Research Development, while Quality
Control Department shall prepare for commercial consignment.
Each Specification & Standard Test Procedure shall have
one Master copy. All additional copies required for distribution shall be
authorized controlled Xerox copies of the Master copy.
RAW MATERIAL SPECIFICATION & STP:
Specifications & STP are in three sections.
First Section: It
is the first page of the Specification. It has the information for, Molecular
formula, Molecular weight, Structural formula, Sampling plan, Sampling Tools,
Sampling Quantity, Reserve Sample, Storage Conditions, Standard Pack Size,
Retest Period & details for the Approved Vendors wherever applicable.
Molecular Formula: This will give the
molecular formula of that Raw Material.
Molecular Weight: This will give the
molecular weight of that Raw Material.
Structural Formula: This will give the
structural formula of that Raw Material if available.
Sampling plan: This will indicate the number of
containers to be sampled. Sample to be
drawn with: This will mention the sampling device to be used for sampling of Raw material.
Sampling Quantity: This will indicate
the minimum quantity of sample to collect from
each container/batch and total quantity to be collected.
Reserve Sample: This will indicate
the quantity of sample to be retained as reserve sample.
Storage Conditions: This will indicate
the storage conditions required for sample.
Standard Pack Size: This will
indicate the unit packs size in which the raw material will be received.
Retest Period: Retest Period
indicates the period when a material should be re-examined to ensure that it is
still suitable for use.
Approved Vendors: This will indicate
the Name of the Approved Vendors for Raw material and Packaging Material.
Second Section: It is subsequent page of the Specification. It
contains the information for the serial number of test, Tests, Test
Specifications and References.
Sr. No.: This will indicate the serial
number of test to be performed.
Tests: This will indicate the name of test to be
performed.
Specification: This will
indicate the acceptance criterion of the test to be performed. This can be range of acceptable values or lower limit /
upper limit of acceptable values or narration of acceptance criteria.
References: Give the reference
as per pharmacopoeia (IP/BP/USP/JP/BIS/HIS-Full Form
Here).
Third Section: It describes particular
test procedures to be followed for the material to be analyzed. It can be a
HPLC method, GC analysis or Titration etc. Based on the Procedure to be
followed the sub-headings are designed.
Whenever the number of test is more than one, it
contains the detail for the Serial No., Test and Test Procedure given in the
second section of the specification.
Sr. No.: This will indicate the serial
number of test to be performed.
Test: This will indicate the name of test to be
performed.
Procedure: This will give detailed procedure
of carrying out the specific test. The procedure should be given in detail with
all necessary testing parameters including reagent preparation.
Procedure:
Executive/Designee-ARD shall prepare Raw Material Specification
& Standard Test Procedure based on the Pharmacopoeial requirements or the
Tentative Specifications received from FRD in the desired format.
In charge/Designee-ARD shall review & check the Raw
Material Specification & Standard Test Procedure for correctness and signs
under the “Reviewed by” column.
In charge/Designee-QAD shall ensure the formatting of
Specifications & Standard test procedure as per SOP and shall sign under
the “Approved by” column.
Based on technology transfer or as per requirement QCD
shall prepare the Specifications & Standard test procedure for all raw
materials for commercial consignment.
If the material is in Pharmacopoeial grade, quality
control department shall prepare the Specifications & Standard test
procedure as per pharmacopoeial requirement.
Executive/Designee-QCD shall prepare Raw Material
Specification & Standard Test Procedure based and sign under the “Prepared
by” column.
In charge/Designee-QCD shall review & check the Raw
Material Specification & Standard Test Procedure for correctness and signs
under the “Reviewed by” column.
In charge/Designee-QAD shall ensure the formatting of Specifications
& Standard test procedure as per SOP and shall sign under the “Approved by”
column.
Sign every page for “Prepared by, reviewed by and then
Approved by” with date. All the pages will have Header, Footer and text as
described ahead.
