Total Quality ManagementTotal Quality ManagementAn industry perspectiveAn industry perspective

LPU 1

Presented by :K.Niranjan GoudM.Pharmacy (QA)

Lovely Professional University, Punjab

Presented by :K.Niranjan GoudM.Pharmacy (QA)

Lovely Professional University, Punjab

Quality is…Quality is…Invisible when GOOD Impossible to ignore when BAD.

LPU 2

Over viewOver view

• Organization• Personnel• Responsibilities • Training• Hygiene• Records • Equipment -Selection Purchase Specifications,• Maintenance, Clean In Place And Sterilize In Place

methods.

LPU 3

The 5M’s of QualityThe 5M’s of Quality

• Man

• Material

• Machinery

• Manuals/Methodology(SOP)

• Motivation

LPU 4

Quality System’s OrganizationQuality System’s Organization

Design ControlsDesign Controls

MaterialMaterialControlsControls

Records,Records, Documents, & Documents, &

Change ControlsChange Controls

Equipment & Equipment & Facility ControlsFacility Controls

Production & Production & Process ControlsProcess Controls

Corrective &Corrective &PreventivePreventive

ActionsActions

ManagementManagement

LPU 5

Organization's purportOrganization's purport

Objectiveso To prevent riskso To detect deviationso To correct errorso To improve efficiencyo To reduce costsHow : By establishing a quality manual

definingo Organizational structure – Staffo Responsibilities o Procedures and processeso Resourceso Documentation

LPU 6

PersonnelPersonnel

Personnel Qualifications • An adequate number of personnel • Qualified by appropriate education, training• Experience to perform • Supervise the manufacture of intermediates and APIs• Specified in writing• Training should be regularly conducted by qualified individuals• Particular operations that the employee performs and GMP as it

relates to the employee's functions.

LPU 7

Personnel Hygiene • Personnel should practice good sanitation and health habits.

• Wear clean clothing suitable for the manufacturing activity with

which they are involved• Clothing should be changed, when appropriate• Necessary wearings• Avoid direct contact with intermediates or APIs.• Restricted to certain designated areas

LPU 8

8.4 – 8.6

.....Personnel.....Personnel

• Minimum number of personnel in clean areaso Especially during aseptic processing

• Inspections and controls from outside• Training to all including cleaning and maintenance staff

o Initial and regularo Manufacturing, hygiene, microbiology

• Special caseso Supervision in case of outside staff o Decontamination procedures (e.g. staff who worked with animal tissue

materials)

LPU 9

8.4 – 8.6

.....Personnel.....Personnel

• High standards of hygiene and cleanliness• Periodic health checks• No shedding of particles• No introduction of microbiological hazards• No outdoor clothing• Changing and washing procedure• No watches, jewellery and cosmetics

LPU 10

Training..Training..

Design and deliver GMP related trainings Training assessment design Recording of assessment

Preparation of training reports.To write training materials

Identification of training requirements Available resources

Preparation of training aid checklists for staffs.

LPU 11

How does good equipment management How does good equipment management

affect Quality assuranceaffect Quality assurance

• Ensures reliable test results and customer satisfaction thus credibility of the lab

• Reduces interruption of services and delays in reporting due to breakdowns

LPU 12

Equipment CriteriaEquipment Criteria

•Selection•Purchase / Acquisition•Installation•Calibration /Validation•Maintenance - Service and repair•Replacement

LPU 13

……..Selection Criteria..Selection Criteria

• Use - Matching equipment with service• Performance characteristics and safety • Facility requirements - - Availability of space, accessibility• Cost• Supply of reagents• Ease of operation• Warranty• Availability of manufacturer technical support• Service Contracts

LPU 14

Economics of maintenanceEconomics of maintenanceMaintenance is a costly activity.

- How much maintenance is needed?- Extent of the maintenance facilities and strength of

maintenance squad.- When and how often ??- Is centralized maintenance desirable? or- Should maintenance be done only by out side contractors.

LPU 15

Preventive MaintenancePreventive Maintenance• Options

o In house service of small equipment, e.g., microscopes, washers, pipetteso Team of biomedical service technicians or AMC by manufacturer

• Regular schedule is usually provided by the firm.• Ensure strict compliance of the schedule.• Ensure all jobs have been performed as per checklist.• Verify the quality of job performed by the firm.

LPU 16

Equipment Maintenance: Documents and records Equipment Maintenance: Documents and records

Equipment History card :A record for equipment inventory Name, Model #, Serial # Location in lab Date purchased Manufacturer and vendor contact information Warranty, expiration date Spare parts

For each piece of equipment: Establish routine maintenance plan Establish required function checks Develop a list of spare parts

LPU 17

10.1 – 10.5

Equipment SterilizationEquipment Sterilization• Sterilizers should be designed with a door at each end • Effective sterilization of equipment• Maintenance and repairs from outside the clean area

o If taken apart, resterilized before useo Use clean instruments and tools

• Planned maintenance, validation and monitoringo Equipment, air filtration systems, sterilizers, water treatment systems

LPU 18

Documentation and RecordsDocumentation and Records

• Is an essential part of the Quality assurance • Specifications for all materials, • Method of manufacture and control• To provide an audit trail Permits investigation of the history of any suspected

defective batch. Electronic data processing methods Authorized persons shall enter modify data

LPU 19

• Documents designed, prepared, reviewed • Documents shall be approved, signed and dated by

appropriate and authorized persons. • Documents shall specify the title, nature and purpose.• They shall be laid out in an orderly fashion and be easy to

check.• Reproduced documents shall be clear and legible. • Documents shall be regularly reviewed and kept up to date.• Any alteration made in the entry of a document shall be

signed and dated.

LPU 20

• The records shall be made or completed at the time of each operation

• Records and associated Standard Operating Procedures (SOP) shall be retained for at least one year after the expiry date of the finished product.

There shall be record of changed and deletions. Batch records electronically stored shall be

protected by a suitable back-up

LPU 21

QUALITY ASSURANCE IS A DYNAMIC PROCESS…

It is a journey towards the destination.

LPU 22