STANDARD OPERATING PROCEDURE
Title Reduced Testing Procedure
Department Quality Assurance Date of Issue
SOP No. QA/029 Effective Date
Revision No. 1.0 Review Due
Supersedes 00 Page No. 1 of 5
1.0 Purpose:
To establish a procedure for Reduced Testing of materials received from approved
vendors.
2.0 Scope:
This procedure is applicable to carry out reduce testing of material from approved
vendors at Joshika Pharma Private Limited
3.0 Responsibility:
All Head of the Department and Department personnel
4.0 EHS Precautions (If any):
5.0 Definitions:
6.0 Procedure:
6.1 Reduce testing For Active pharmaceutical ingredient:
6.1.1 Three consecutive batches from a approved vendor shall be tested
completely as perthe In-house or Compendial test methods.
6.1.2 If all the Three batches confirm to meet the predetermined specifications
as per COA then the reduced testing shall be performed for future supplies.
6.1.3 During reduced testing; the following tests shall be performed.
(a) Description
(b) At least one Identification.
(c) LOD / Moisture
(d) Assay but not limited too.
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Format No.: FM/JP/QA/001/01 Rev. No.: 4.0
STANDARD OPERATING PROCEDURE
Title Reduced Testing Procedure
Revision No. 1.0
SOP No. QA/029
Page No. 2 of 5
6.1.4 The complete testing shall be repeated for every 20th batch or 1 batch per
year, whichever is earlier.
6.1.5 If API manufacturer changes the process and changes are accepted by
Joshika, then again the first three batches supplied by the API manufacturer
by following the new process shall be tested completely as per the In-House
method or compendial methods. Subsequently the reduced testing shall be
performed as described above.
6.2 Excipients :
6.2.1 Three consecutive batches from a approved vendor shall be teste
completely as per the In-house or compendial test methods.
6.2.2 If all the Three batches confirm to meet the predetermined specifications as
per COA then the reduced testing shall be performed for future supplies.
6.2.3 During reduced testing, the following tests shall be performed.
(a) Description
(b) At least one identification
(c) Microbiology testing, wherever applicable.
6.2.4 The complete testing shall be repeated for every 30 th batch or 1 batch per
year, Which ever is earlier.
6.2.5 If vendor changes the process and changes, then again the first three batches
supplied by the vendor by following the new process shall be tested
completely as per the In-House method or compendial methods.
Subsequently the reduced testing shall be performed as described above.
6.3 Primary & Secondary Packaging Materials : (HPDE Drums, LDPE bags)
6.3.1 Three consecutive batches from a qualified vendor shall be tested
completely as perthe In-house or compendial test methods.
6.3.2 If all the ten batches confirm to meet the predetermined specifications as
per COA then the reduced testing shall be performed for future supplies.
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Format No.: FM/JP/QA/001/01 Rev. No.: 4.0
STANDARD OPERATING PROCEDURE
Title Reduced Testing Procedure
Revision No. 1.0
SOP No. QA/029
Page No. 3 of 5
6.3.3 During reduced testing, the following tests shall be performed.
[Link] Description
[Link] Dimensions / Physical parameters , wherever applicable
[Link] Identification, wherever applicable.
6.3.4 The complete testing shall be repeated for every 30 th batch or 1 batch per
year, whichever is earlier.
6.4 If the manufacturer changes the process of source or resin (wherever
applicable),then complete testing shall be performed for the first three batches.
Subsequently the reduced testing shall be performed as described above.
6.5 The QC manager or his designee shall also verify if there are different grade of the
same material and their individual specifications and identify the differentiating
tests. This test shall be added to the reduced testing proposal.
6.6 Complete testing shall be done for every 20th batch of API’s and for every 30th
batch of excipients, primary and secondary packing materials OR 1 batch per year
whichever is earlier.
6.7 If a material fails to meet the specification and the OOS investigation concludes the
absence of analyst error, based on QA recommendation, QC - Head or his / her
designee shall make "Reduced Testing Programme Suspended" under the remarks
column of GRN form.
6.8 Next three consignments shall be tested for complete analysis.
6.9 Modify the status of this suspension after getting further directions from QA.
Indicate the same in the remarks column in GRN form.
6.10 If the three consecutive consignments fail as per the specification the vendor shall
be requalified as per the Vendor Qualification SOP. QA023
7.0 Annexures:
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Format No.: FM/JP/QA/001/01 Rev. No.: 4.0
STANDARD OPERATING PROCEDURE
Title Reduced Testing Procedure
Revision No. 1.0
SOP No. QA/029
Page No. 4 of 5
Annexure-1: Goods Receiving Note (Format No.: FM/JP/QA/029/01)
8.0 Reference:
9.0 Abbreviations:
HDPE : High Density Polyethylene
LDPE : Low Density Polyethylene
LOD : Loss On Drying
API : Active pharmaceutical ingredient
GRN : Goods Receiving Note
10.0 Revision History:
Revision No. Effective Date Reason for Revision
1.0
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Format No.: FM/JP/QA/001/01 Rev. No.: 4.0
STANDARD OPERATING PROCEDURE
Title Reduced Testing Procedure
Revision No. 1.0
SOP No. QA/029
Page No. 5 of 5
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Format No.: FM/JP/QA/001/01 Rev. No.: 4.0