Equipment Compliance Requirement from the Regulatory Perspective

1. ARTICLE
Equipment Compliance Requirement from the
Regulatory Perspective
J.Ramniwas*
CEO, Sai Pharma Solutions Inc., Vadodara.
Equipment used in the manufacture, 1. That the equipment is installed according 3. Equipment Description
processing, packing, or holding of a drug to the manufacturer’s instructions. 4. Responsibilities
product should be of appropriate design,
2. That the equipment is operated properly 5. Identification and Verification of the
adequate size, and suitably located to
and consistently. equipment system
facilitate operations for its intended use and
for its cleaning and maintenance. Process 3. That the equipment performs within 6. Identification and verification of major
equipments play a very important role for the requirements determined by the components
delivering drug products of impeccable and facility.
7. Identification of process control
consistent quality. Right from the design The journey of equipment qualification instruments
and construction to routine usage, care starts from the User Requirement
should be taken to minimize the risk of 8. Verification of correct installation and
Specifications which are discussed with the calibration
contamination so that the patients get quality vendor and based on the agreement signed.
medicines all the times. The user requirement specifications cover 9. Identification and Verification of direct
the following details about the equipment: contact surfaces
Design 10. Identification and verification of required
1. Process/ Product Requirements
utilities
The design of process equipment used
2. Operational Requirements
11. Identification and verification of required
in the manufacture of drug substances and
drug products should be of appropriate 3. GMP/GLP Requirements documentation
design and adequate size, and suitably 4. Safety Requirements 12. Deviation and Corrective Actions
located for its intended use and there should
5. Documentation Requirements 13. Summary Report
be an ease in cleaning, sanitization and
maintenance. 6. Discussion/Review/Comments After installation qualification, the
equipment is subjected to operational
Based on URS, the equipment design
Construction is discussed and equipment design
qualification where each and every
component and control panel is tested for
The construction of the equipment qualification is undertaken. The protocol
its functional and operational requirements
should be undertaken in such a way that of design qualification covers the following
to ensure the suitability of the operation
the surfaces in contact with the components, parameters:
of components and control panels for
in-process materials, or drug products are 1. Preapproval their intended use. During operational
not reactive, additive, or absorptive so as to qualification, the training needs are identified
2. Overview
alter the safety, identity, strength, quality or and all procedures for the routine use
purity of the drug product beyond the official 3. Acceptance Criteria
of the equipment become effective. The
or other established requirements. 4. Description of Equipment operational qualification protocol contains
5. Statement of Qualification the following informations:
Any substance which is required for
operation of the equipments such as 6. Design Qualification Final Report 1. Objective
lubricants or coolants should not come into 7. Post Approval 2. Scope
contact with components, drug product 3. Equipment Description
containers, closures, in-process materials, After the design Qualification, the
factory acceptance testing (FAT) is 4. Responsibilities
or drug products so as to not alter the safety,
identity, strength, quality, or purity of the undertaken jointly by the customer and 5. Identification of OQ tests and conducting
drug product beyond the official or other vendor engineering team. Once FAT is the functional tests
established requirements. The lubricants approved, the equipment is dispatched to 6. Verification of calibration of critical
the customer’s end and over there SAT (Site process instruments
used should be of food grade.
Acceptance Testing) is undertaken by the
engineering team of the customer. Once the 7. Identification and verification of functional
Equipment Qualification equipment meets the SAT requirements, it is tests for interlocks and alarms
Equipment qualification is a necessary subjected to installation. The IQ (Installation 8. Identification and verification of functional
and critical step in ensuring that a product or Qualification) Protocol contains the following tests for safety and security
service is provided accurately and is consist- information: 9. Identification and verification of SOPs
ent with the requirements. Following are the 1. Objective
prerequisites of equipment qualification: 10. Identification and verification of training
2. Scope needs
*Email id: info@saipharmasolutions.com
Pharma Times - Vol. 43 - No. 10 - November 2011 29

2. 11. Deviation and Corrective Actions 5. Instructions for the removal or obliteration Incidents related to computerized systems
12. Summary Report of previous batch identification. that could affect the quality of products or
The consistent performance of the 6. Instructions for the protection of clean the reliability of records or test results should
equipment to manufacture products of equipment from contamination prior to be recorded and investigated. Changes to
impeccable quality is determined by the use. the computerized system should be made
performance qualification. The preventive 7. Inspection of equipment for cleanliness according to a change control procedure and
maintenance of equipments is also a part immediately before use. should be formally authorized, documented
of the performance qualification. Some and tested and records thereof should be
8. Establishing the maximum time that
regulatory guidelines address preventive maintained. The computerized data should
may elapse between the completion of
maintenance separately under maintenance be protected and should be secured in the
processing and equipment cleaning.
qualification (MQ). Preventive maintenance incremental order.
is the key for the consistence performance Periodic Review of Validation/ Documentation
of the equipment. The performance Qualification Status
Documentation is the evidence of
qualification protocol contains the following All the qualified equipments should be execution of any activity. From the regulatory
details: periodically evaluated to verify that they perspective, following documents for
1. Purpose are still operating in a valid manner. There the equipment should be prepared and
2. Description should be an annual review and conclusion maintained:
3. References should be drawn whether equipment stands 1. Equipment qualification protocols and
4. Responsibilities in validated state or not. If the equipment reports (URS, DQ, FAT, SAT, IQ, OQ
5. Performance Qualification (Test Plan) or the system is consistently producing and PQ).
6. PQ Acceptance Criteria material meeting its specifications, there is 2. Standard Operating Procedure for
7. Modification/ Change Control and normally no need for revalidation. Operation, Calibration, Cleaning and
Revalidation
Change Control maintenance.
8. Comments/ Action Items
3. Sequential log books.
9. PQ Attachments Any changes in the equipment which 4. Calibration, Cleaning and Preventive
• Test Data Sheet can have impact on the product quality maintenance records.
• Test Instrument Calibration and should be addressed through the change 5. Change control and deviation records.
Analytical Instrument Validation control system depending upon the nature of 6. History cards etc.
Calibration impact of the change on the product quality.
The regulatory requirements for the
The test equipments which are equipped They may cause major and minor impacts
on product quality. All changes related to the equipments are becoming stringent day by
with test instruments and are used for the day as there has been a paradigm shift in
control, weighing, measuring, monitoring equipments should be evaluated based on
the criticality of the operation and impact on the focus of regulatory auditors. The key
and are critical for assuring the quality criterion has been risk management and
of drug substances and drug products the product quality.
product safety. All manufacturers will have
should be calibrated according to written Computerized Systems to comply with all the forthcoming challenges
procedures and the established schedule. to stay in pharmaceutical business.
GMP related computerized systems
Calibrations should be performed using
should be validated
standards traceable to certified national
depending upon the Advertisers’ Index
and international standards like NPL or
diversity, complexity
NIST. The calibration records should be Sr. No. Company Name Page No. Sr. No. Company Name Page No.
and the critical nature
maintained and calibration status label 1. A H Industries .................................78 23. Integrated Cleanroom
of the computerized
should be displayed. The Instruments that 2. Accin Packaging Pvt. Ltd. ...............98 Technologies Ltd. ............................49
application. The
do not meet calibration criteria should not 3. Accupack Engineering Pvt. Ltd. ......99 24. IMA-PG India Private Ltd. .................4
installation qualification
be used. 4. Accura Pharmaquip Pvt. Ltd. ..........91 25. Krishtech Solutions .........................88
and operational
Maintenance and Cleaning qualification should 5. Adam Febriwerk Pvt. Ltd. ................98 26. Kesari Tours & Travels ....................97
27. Kevin Process
demonstrate the 6. Agam & Gem Engineers .................88
There should be standard operating Technologies Pvt. Ltd. .....................85
procedures in place for the preventive suitability of computer 7. Ambica Pharma .............................101
28. Labtop Instruments Pvt. Ltd. ...........84
maintenance and cleaning of all equipments. hardware and software 8. Ami Polymer Pvt. Ltd. ......................92 29. Labsystems & Biotech (I) Pvt. Ltd. ..55
There should be a preventive maintenance to perform assigned 9. API & bFormulation Unit for Sale ....50 30. N. K. P. Pharma Pvt. Ltd. ................87
program for all equipments and it should tasks. There should 10. Bectochem Consultants & 31. National Pharma Machinery ............77
be controls to prevent Engineers Pvt. Ltd. ........................ 94,95 32. Newtronic Equipment
be followed as per the check list provided. 11. Brothers Pharmamach (India)
Similarly, cleaning of equipments is of omissions in data (e.g. Company Pvt. Ltd. ...........................14
Pvt. Ltd. ...........................................90 33. Nimach Engineering Co. .................88
utmost importance in the prevention of system turned off and
12. Cadmach .........................................79 34. Parle ................................................82
batch to batch and product to product data not captured).
13. Captech Engineers ..........................92 35. Precitech Industries .........................89
contamination. There should be a
14. Cealsons Industries .........................88 36. Promas Engineers Pvt. Ltd. ..............8
record of any data
The cleaning procedure should contain 15. Centre for Clinical Research & 37. Sannira Associates .........................89
change made, the
Training ...........................................36 38. Shreeji PharmaTech .......................93
the following: previous entry, who
16. Chamunda .....................................100 39. Tapasya Engineering Works Pvt. Ltd. . 83
1. Assignment of responsibility for cleaning made the change,
17. Cronimach .......................................56 40. Target Innovations ..........................93
of equipment. and when the change
18. Dhara Engineers .............................80 41. Technofour Electronic Pvt. Ltd ........86
2. Cleaning and sanitizing schedules. was made. There
19. Dipesh Engineering Works ..............05 42. Thermo Scientific ..............................6
3. A complete description of the methods should be written 43. Thermolab Scientific Equipment .....12
20. Elmach Packages (India)
and materials. standard procedures Pvt. Ltd. ...............................52,53,102 44. TSA Process Equipments Pvt. Ltd. .81
for the operation 45. UBM India Pvt. Ltd ..........................51
4. Instructions for disassembling and 21. Fabtech Technologies
and maintenance of International Ltd. ..................2,3,13,15 46. Universal Madicap Ltd. ....................54
reassembling each article of equipment
computerized systems. 22. Galaxy Shivtek ................................36 47. West Pharma ..................................10
to ensure proper cleaning.
Pharma Times - Vol. 43 - No. 10 - November 2011 30