Standard Operating Procedure of Instrument / Equipment / System Qualification in Pharmaceuticals is describe in this post.
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1. PURPOSE
This SOP outlines the procedure to assure that all the Instruments / Equipments / Systems present in RM/PM Warehouse, Production, Q.C and Maintenance departments, meet user requirements and Manufacturers’ Specifications.
2. SCOPE
This procedure is applicable to all the Instruments / Equipments / Systems in RM/PM Warehouse, Production, Q.C and Maintenance departments.
3. RESPONSIBILITY
3.1 All the concerned Deptt. Heads / Section Incharges are responsible to conduct qualification studies of Instruments / Equipments / Systems in their Deptt. / Sections.
3.2 All the Supervisors and machine operators are responsible for Instruments / Equipments / Systems operation and Section Incharge / Officer are responsible for recording of relevant data.
3.3 Design Qualification is prepared by respective Deptt. (User).
3.4 Installation and operational Qualifications can also be performed by Vendor.
3.5 Head of Deptt. and Section Officer verifies the vendor qualifications and records.
3.6 If Qualification study is carried out by Deptt. / Section itself, then officer performs the qualification and records the information.
3.7 Officer assigned by Section Head fills the protocol, get it reviewed & approved from qualification team & performs the qualification.
3.8 Head of Deptt. / Executive Q.A Validation supervises the study and verifies the completion of the records.
3.9 Maintenance Incharge helps the Deptt. (User) in all Qualification studies (when required).
3.10 Executive Q.A Validation assists the concerned Deptt. in all Qualification studies and reviews the Qualification Protocols and Reports.
3.11 Executive Q.A Validation monitors overall activities regarding Equipment Qualifications.
3.12 Q.A Manager approves all the Qualification Plans, Reviews, Protocols and Reports.
4. MATERIAL & EQUIPMENT
4.1 Instrument / Equipment / System to be qualified.
4.2 DQ/IQ/OQ/PQ formats/ Forms of manufacturer of instruments if of international standards can be used.
4.3 Equipment Qualification Label.
5. PROCEDURE
5.1 All the newly purchased and relocated (e.g., from previous site) Instruments / Equipments / System present in RM/PM Warehouse, Production, Q.C and Maintenance departments are subjected to Qualification.
5.2 Equipment Qualification team decides,
5.2.1 Which Instrument / Equipment / System will be subjected to Qualification Study,
5.2.2 Which type of Qualification is required by each Instrument / Equipment / System.
5.2.3 What tests to be performed for each Instrument / Equipment / System.
5.2.4 When each Instrument / Equipment / System will be subjected to Re-Qualification.
5.3 Equipment Qualification team comprises of following persons,
5.3.1 Officer of the concerned section,
5.3.2 Head of Deptt. of concerned section,
5.3.3 Maintenance Incharge (where required),
5.3.4 Quality Control Manager (where required),
5.3.5 Executive Q.A Validation,
5.3.6 Quality Assurance Manager.
5.4 List of Instruments / Equipments / Systems of each section selected for qualification is prepared by Section Officer along with HOD, Executive Q.A Validation and Q.A Manager.
5.5 Section Officer keeps the copy of this list and sends original to Q.A department.
5.6 This list can be changed (if required) with the authorization of Q.A department.
5.7 With the help of this list, Executive Q.A Validation prepares/ updates “Review of Equipment Qualification Activity” excel sheet.
5.8 Head of Deptt., Officers and machine operators are directly involved in Instrument / Equipment / System Qualification.
5.9 Maintenance Deptt. assists in conduction of all types of Qualifications and recording of relevant data (when required).
5.10 Functional / Operational specifications of an Instrument / Equipment / System taken from quotation / manual etc., or if manual is not available then existing Functional / Operational specifications along with acceptable upper and lower limits are made by equipment qualification team.
5.11 Executive Q.A Validation assists the concerned Deptt. in all Qualification studies and monitors overall activities of Equipment Qualification.
5.12 Executive Q.A Validation with the assistance of respective HOD prepares the protocol & gets its final approval from Q.A Manager.
5.13 Equipment Qualification # is assigned by method given below.
5.14 DQ, IQ, OQ and PQ numbers are assigned by QA Deptt. for each Instrument / Equipment / System from “Review of Equipment Qualification Activity” excel sheet.
5.15 For giving Equipment Qualification # a uniform numbering System is followed as XQ/DD/000
XQ = TYPE OF QUALIFICATION
DD = DEPARTMENT/ SECTION
000 = SERIAL NUMBER
EXAMPLE: DQ/QC/001
5.16 Serial Number for DQ, IQ, OQ and PQ of one Instrument / Equipment / System is same.
EXAMPLE: DQ, IQ, OQ and PQ for Disintegration Apparatus (present in Q.C.) is,
DQ # = DQ/QC/001, IQ # = IQ/QC/001, OQ # = OQ/QC/001 and PQ # = PQ/QC/001
5.17 Serial Number starts from 001 for each Department / Section.
5.18 Approved Qualification Protocol along with relevant documents is kept by Quality Assurance Department.
5.19 After Successful completion of Instrument / Equipment / System Qualification a Label “Equipment Qualification” is filled by Executive Q.A Validation and paste on that Instrument / Equipment / System.
5.20 Equipment Qualifications are of following types,
5.20.1 DESIGN QUALIFICATION (DQ)
a. It is conducted for all the newly purchases Instrument / Equipment / System.
b. Design Qualification is carried out as per SOP “Design Qualification”.
c. Design Qualification results are recorded on “Design Qualification Protocol & Report”.
5.20.2 INSTALLATION QUALIFICATION (IQ)
a. Installation Qualification is performed after successful completion and approval of DQ report.
b. It is conducted for all the newly purchased and relocated (e.g., from previous site) Instrument / Equipment / System.
c. Installation Qualification is carried out as per SOP “Installation Qualification”.
d. It may be carried out by vendor (vendor may use his own format for reports) or Deptt. / Section itself.
e. Installation Qualification results are recorded on “Installation Qualification Protocol & Report”.
5.20.3 OPERATIONAL QUALIFICATION (OQ)
a. Operational Qualification is performed after successful completion and approval of IQ report.
b. Operational Qualification is carried out as per SOP “Operation Qualification”.
c. It may be carried out by vendor (vendor may use his own format for reports) or Deptt. / Section itself.
d. Operational Qualification results are recorded on “Operation Qualification Protocol & Report”.
5.20.4 PERFORMANCE QUALIFICATION (PQ)
a. Performance Qualification is performed after successful completion and approval of OQ report.
b. Performance Qualification is carried out as per SOP “Performance Qualification”.
c. It may be carried out by vendor (vendor may use his own format for reports) or Deptt. / Section itself.
d. Performance Qualification results are recorded on “Performance Qualification Protocol & Report”.
5.21 Any deviation observed is evaluated by qualification team for its root cause, impacts and its acceptance. If deviation does not effects the output of the Instrument / Equipment / System or it enhances the working of the Instrument / Equipment / System then it is accepted otherwise Instrument / Equipment / System is replaced (in case of newly purchased Instrument / Equipment / System) or repaired (in case of old Instrument / Equipment / System), so that it meets the qualification requirements.
5.22 At the end of Qualification Study, Re-Qualification date is decided by Qualification team.
5.23 RE-QUALIFICATION
Re-Qualification is divided into two categories:
5.23.1 RE-QUALIFICATION AFTER CHANGE
This may be carried out after,
a. Major Break Down
b. Major Maintenance or Modification
c. Relocation (or change of environment, if critical)
d. Out of Specification results
5.24 PERIODIC RE-QUALIFICATION
5.24.1 Periodic Re-Qualification checks that the Instrument/ Equipment / System is still operating as originally validated.
5.24.2 Periodic Re-Qualification is done after 1 to 5 years decided by Equipment Qualification Team.
5.25 REVIEWING OF QUALIFICATION ACTIVITIES
5.25.1 Equipment qualification status of each section is updated by Executive Q.A Validation on excel sheet “Review of Equipment Qualification Activity”.
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