STANDARD OPERATING PROCEDURE

LUPIN Mandideep

SOP No.:QAD-SOP-129 Page No: 1 of 4

VALIDADTION OF EQUIPMENT
Revision No.: 00 Effective Date:
CLEANING PROCEDURE (API)
Quality Assurance Review Period: 2 Years

1.0 OBJECTIVE:

To lay down a procedure for validation of equipment cleaning procedure.

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:

General Manager Manufacturing shall be accountable for implementation and compliance

of this procedure.

5.0 DEFINITIONS:

SOP : Standard Operating Procedure

QA : Quality Assurance

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.

PREPARED BY CHECKED BY APPROVED BY

DATE DATE DATE

Format No.: QAD-SOP-001/F1-00

 STANDARD OPERATING PROCEDURE

LUPIN Mandideep

SOP No.:QAD-SOP-129 Page No: 2 of 4

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:

Validation Execution Team Responsibilities

Officer / Sr. Officer / Executive-
Production
Officer / Sr Officer / Executive-
Quality Control
Officer / Sr. Officer / Executive-
Engineering
Officer / Sr. Officer / Executive-
Quality Assurance
Execution of Cleaning Validation
and Data Compilation
Analysis of Validation Samples,
Recovery Studies for each product.
Providing Equipment Surface Area for each
Equipment
Coordination and Review

PREPARED BY CHECKED BY APPROVED BY

DATE DATE DATE

Format No.: QAD-SOP-001/F1-00

 STANDARD OPERATING PROCEDURE

LUPIN Mandideep

SOP No.:QAD-SOP-129 Page No: 3 of 4

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.

6.10 Revalidation shall be done in any of the following cases:

Addition of New Product / intermediate in the Facility
Any Change in Acceptance Criteria

7.0 REFERENCE DOCUMENTS:

Not Applicable

8.0 ANNEXURE (S):

Annexure I: Cleaning Validation Protocol Format

Annexure II: Cleaning Validation Report Format

9.0 DISTRIBUTION:

Master Copy : Quality Assurance

Control Copy 1 : Bulk Drug Facility (Phase I)
Control Copy 2 : Sterile Cephalosporins Facility (Phase II)
Control Copy 3 : Crystalline Sterile Bulk Facility (Phase III) CSB Area
Control Copy 4 : Bulk Drug Facility (Phase IV)
Control Copy 5 : Bulk Drug Facility (Phase V)
Control Copy 6 : Crystalline Sterile Bulk Facility (Phase III) NSB Area
Control Copy 8 : Multipurpose Pilot Plant
Control Copy 10 : Quality Control
Control Copy 14 : Cardio Vascular (API-I) Facility
Control Copy 19 : Cardio Vascular (API-IV) Facility

PREPARED BY CHECKED BY APPROVED BY

DATE DATE DATE

Format No.: QAD-SOP-001/F1-00

 STANDARD OPERATING PROCEDURE

LUPIN Mandideep

SOP No.:QAD-SOP-129 Page No: 4 of 4

VALIDADTION OF EQUIPMENT
Revision No.: 00 Effective Date:
CLEANING PROCEDURE (API)
Quality Assurance Review Period: 2 Years

Control Copy 28 : Quality Assurance

Control Copy 29 : Quality Assurance, Cardio Vascular
Control Copy 30 : Quality Control, Cardio Vascular

10.0 HISTORY OF SOP:

Revision Effective Date Reasons for Change

No
00 New Standard Operating Procedure

PREPARED BY CHECKED BY APPROVED BY

DATE DATE DATE

Format No.: QAD-SOP-001/F1-00