Qad Sop 129
Qad Sop 129
Qad Sop 129
LUPIN Mandideep
VALIDADTION OF EQUIPMENT
Revision No.: 00 Effective Date:
CLEANING PROCEDURE (API)
Quality Assurance Review Period: 2 Years
1.0 OBJECTIVE:
2.0 SCOPE:
This SOP shall be followed at Mandideep location in all API facilities for validation of the
equipment cleaning procedure.
3.0 RESPONSIBILITY :
Plant Manager shall be responsible for the implementation of this Standard Operating
Procedures.
4.0 ACCOUNTABILITY:
5.0 DEFINITIONS:
6.0 PROCEDURE:
6.01 The cleaning procedure for the equipment shall be validated wherever more than one
products / Intermediates shall be processed in the same equipment.
6.02 The Production officer shall prepare a Cleaning Validation Protocol in the specified format
(Annexure 1), which shall include in detail Validation Methodology, Acceptance Criteria,
Sampling Procedure and Sampling Locations. The Validation Protocol shall be approved
by Head Production and Authorised by Head Quality Assurance.
LUPIN Mandideep
VALIDADTION OF EQUIPMENT
Revision No.: 00 Effective Date:
CLEANING PROCEDURE (API)
Quality Assurance Review Period: 2 Years
6.03 The Cleaning Validation Protocol shall establish / calculate the Acceptance Limits for
Swab and Rinse samples based on Maximum Allowable Carryover calculations or any
other rational and justified method.
6.4 The sampling procedure shall define the sampling techniques to be used, a detailed
procedure to collect the samples and the sampling locations represented as Hard to
Clean.
6.5 The analytical Method Validation shall be separately done for the analysis of Cleaning
Samples and shall essentially include Limit of Detection (LOD) and Limit of Quantitation
6.6 The Recovery Studies shall be done for each product by Quality Control Department for both
rinse and swab samples. A Separate protocol and Report shall be prepared by Quality
Control Officer / Executive which shall be approved by Head Quality Assurance.
6.7 The Product Contact Equipment Surface Area calculations shall be done by Engineering /
Projects Department and attached as Equipment Surface Area Calculation sheet in IQ for
each equipment.
6.8 The Cleaning Validation shall be executed by a Validation Team. The Construction and
responsibilities shall be as follows:
LUPIN Mandideep
VALIDADTION OF EQUIPMENT
Revision No.: 00 Effective Date:
CLEANING PROCEDURE (API)
Quality Assurance Review Period: 2 Years
6.9 After execution of Cleaning Validation a report shall be prepared by production in the
Specified manner (Annexure II) and approved by Head Production and Authorised by
Head Quality Assurance.
Not Applicable
9.0 DISTRIBUTION:
LUPIN Mandideep
VALIDADTION OF EQUIPMENT
Revision No.: 00 Effective Date:
CLEANING PROCEDURE (API)
Quality Assurance Review Period: 2 Years