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Quality Control Management System (QCMS)

Quality Control Management System (QCMS)

Introduction:
Quality Control department was entrusted or assigned the responsibility of small Q traditionally. The laboratory chemists were more of finding and detecting the defects rather than controlling the quality. With the shift in paradigm and the advent of Quality by Design (QbD) the importance of Quality Control as an effective tool to assess the risk, mitigate the risk and control the critical attributes which later on contribute to build up the Quality of the product and can thus serve as a check point to build up the desired quality product was realized and thus the new concept of QCMS was conceptualized by Quality organizations.

Quality Control Department hereafter referred in context to the Pharmaceutical Industry as such comprises of following basic sections (the list is not exhaustive and may vary from organization to organization depending upon the organizational goal and objective):
 Raw Material Section
 In process
 Finished Product
 Stability
 Validation
 Good Laboratory Practices (GLP)
 Microbiology
 Documentation

The general flow of QC:
Receipt of GRN / Intimation of sampling A R No. generation Sampling as per SOPTesting as per Product Specification and Method of Analysis  Disposition.

Various activities and skill sets can be grouped as follows:
1. Wet Chemistry
 Chemical tests
 physical tests
2. Instrumentation
 Chromatography (GC & U/HPLC) ,
 Spectroscopy (FTIR, UV visible, FTNIR)
3. Dissolution Lab
 Single point
 Multipoint profiling
 Conventional dosage form
 Modified Release(Enteric coated and sustained release)
4. Microbiology
 MLT
 BET
 Sterility
 Water
 Environmental monitoring
 Bioassay
 Media fill / Process Simulation


Section wise overview:


A. Raw Material (RM)
 API
 Excipients
Activities:
 Sampling
 Testing- Specifications, Method of Analysis, Worksheet, C of A
 Disposition
 Destruction of remaining samples
 Retention samples

B. Packaging Material (PM)
 Primary packaging
 Secondary Packaging
 Printed Packaging material
 Artwork
Activities:
 Sampling- Military standards / ISO standards
 Testing- Specifications, Method of Analysis, Worksheet, C of A
 Disposition
 Destruction of remaining samples
 Retention samples

C. Finished Product and In-Process (FP)
 Inprocess- blend, triturate, bulk, core
 FP- After pack
Activities:
 Sampling- IPQC
 Testing- Specifications, Method of Analysis, Worksheet, C of A
 Disposition
 Destruction of remaining samples
 Retention samples

D. Stability Studies- As per ICH
 Accelerated Condition-40° ± 2 / 75% ± 5
 Controlled Room Temperature- 30° ± 2 / 75% ± 5 (may vary depending upon the Zone)
 Long term- 25° ± 2 / 60% ± 5(may vary depending upon the Zone)

Activities:
 Sampling- IPQC
 Testing- Specifications, Method of Analysis, Worksheet, C of A
 Disposition
 Destruction of remaining samples
 Retention samples

E. Validation / Qualification:
 Method Validation (Analytical Method Validation, Microbial Method Validation)
 Cleaning Validation- Swab, rinse, placebo, CIP
 Process validation- Retrospective, Concurrent, Prospective
 Instrument Validation (Analytical Instrument Qualification)- URS, DQ, IQ, OQ, PQ
 Analyst Validation / Qualification (New comer & routine)
 Computer System Validation (CSV)

Activities:
 Validation protocol
 Validation report
 Training matrix

F. Good Laboratory Practices(GLP)
 Analytical Assurance
 Issuance
 Compliance

Activities:
 Calibrations (Calibration Schedule)
 Preventive Maintenance (PM Schedule)
 Training matrix (New Comers / regular)
 Working Standards / Reference Standards Management
 User administration (21 CFR)
 Data backup & restoration (Disaster mitigation)
 Column management(HPLC, GC)
 Chemicals- Receipt, Storage and Consumption
 Issuance- Log books, Work sheets, Calibration formats
 OOS, Change management, Deviations

G. Documentation
 Normative Documents (ND)- Registration, re-registration
 SOPs, Worksheets, Protocols, Reports, C of A



Reference Guidelines for implementing the QMS in QC:
 ICH (Q10)
 PIC/S
 USP
 Orange Book (MHRA)
 ISO (QMS)

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