Top Tactics for Maximizing GMP Compliance in Blue Mountain RAM

snowpeaschocolateΔιαχείριση

18 Νοε 2013 (πριν από 3 χρόνια και 8 μήνες)

73 εμφανίσεις

Top Tactics for Maximizing GMP
Compliance in Blue Mountain RAM


Jake
Jacanin
, Regional Sales Manager

September 18, 2013

Presentation Objectives


Convey importance of asset and event mgt


Communicate systems approach to asset mgt


Show broad scope and intricacies involved


How to meet national and international
regulations using Blue Mountain RAM









Presentation Overview


Asset compliance definitions


Relevant regulatory observations and findings


Current compliance trends and observations


Compliant
cGLP

and cGMP asset mgt


Quality Systems approach to asset mgt



Top 10 GMP Deficiencies Categories


Documentation of manufacturing and related
activities


Design and maintenance of premises and systems


Documentation availability and accessibility of
records


Personnel training and qualifications


Design and maintenance of equipment and systems



Top 10 GMP Deficiencies Categories


Cleaning validation and testing


Equipment and process validation controls mgt


Product quality review


Supplier, contractor, vendor control and audit


Calibration of measuring and test equipment

Life Sciences Regulatory Trends


Quality Systems inspections increased


Regulatory inspections increased significantly


Citations and violations increased significantly


Warning letters doubled over past several years





Relevant Definitions


FDA Warning Letter


Correspondence to company representative


Noncompliance to regulatory standards (CFR’s)


FDA Form 483


Notice of inspectional observations identified


Consent Decree


Voluntary order or judgment between parties





Relevant Definitions


Voluntary compliance


Acknowledgment and corrective action


Assets


Equipment, instrument, system, location,
personnel


Events


Calibration, PM, validation, testing, NCR,
training, cleaning


Quality System


Personnel performing policies, practices,
procedures







FDA
483 Observations

Failure to:


“Adequately establish
procedures

to ensure
equipment routinely calibrated, inspected &
maintained”


“Follow
preventive maintenance schedule

outlined”



Maintain buildings in a good state of repair




Validate a computer database

used for a quality
function”


“Have
SOP’s
ensure equipment routinely serviced”


“Develop & maintain
documentation of calibrations



Systems Approach Example

Compliant Asset Management Process

Asset:


Assessment: Purpose, role, worthiness


Determination: Importance relative to product


Induction: Approach, process and methodology


Classification: Criticality and risk relative to product


Specification: Service events and services required


Compliant Asset Management Process

Asset:


Servicing: Depth, detail and frequency


Coordination: Event forecast, schedule and
notification


Personnel: Qualifications: Internal and external


Preparation: Availability of standards, tools and
parts


Procedure: Detailed direction for performing event


Compliant Asset Management Process

Asset:


Reporting: Event outcome, status and availability


Actions: Active, repair required, obsolete/ retire


Recording: Means to record, document findings


Labeling: Label generation based on asset status


Deviations: Document and communicate findings



Compliant Asset Management Process

Asset:


Review: Analyze and approve event results


Recall: Next event generated automatically


Changes: Role, parts, specifications, locations


Approval: Review and approval of changes


Measurement: KPI’s, metrics and analytics



Asset Induction

Specification Form


Manual Method

Who is Responsible to Specify?

Under a quality system, the technical experts who
have an understanding of pharmaceutical science,
risk factors, and manufacturing processes related
to the product, are responsible for defining specific
facility and equipment requirements
1






1
FDA “Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP
Regulations”


Asset Classification
-

Criticality


Asset

Criticality Assessment



Evaluation of assets role in production of product


Potential impact
to Product, Process, Safety


Collaborative process using qualified people


e.g. Owner, Quality, Engineering, Metrology,
Maintenance


GAMP Classifications


Critical


Non
-
critical


No Impact











Asset Criticality Classification


Identify and determine asset purpose and role


HPLC monitors products purity


Document assets classification and rational


Asset is
critical

since it
monitors product purity


Process provides gains in productivity


Perform with new and repurposed assets

Review and Approval

Under cGMP regulations, the quality unit (QU) has
the responsibility of reviewing and approving all
initial design criteria & procedures pertaining to
facilities & equipment & any subsequent changes
(
§

211.22c)




1
FDA “Guidance for Industry: Quality Systems Approach to Pharmaceutical
cGMP

Regulations”


Personnel


Who is Qualified?


Manage training for personnel and contractors


Recall and document periodic training events


Establish levels of required expertise “Crafts”


Specify and assign work by craft and expertise

Personnel Record

Vendor and Contractor Management


Manage vendors and contractors


Document contact and contract info


Document and embed contracts and req’s


Document and maintain performance


Recall events for audit and contract review








Parts Inventory and Records

Job Plan

Work Event Scheduling

Specification e.g.


Calibration Data

Procedure: Detailed and Criteria

Labeling

CALIBRATION LABEL

ID: SPS
-
1

Cal Date: 02/ 06/2013

Due Date: 03/06/2013

Technician: JAJ

Asset Non
-
Conformance

Asset Event Deviation
-
NCR

Change Request and Review

Measurements and Metrics

Conclusion


CFR Reg’s mandate compliant asset
management


Scope is broad, intricate and challenging


Quality Systems approach is required


Systems approach increases success rate


Agencies expect show and tell


Blue Mountain RAM: Best solution to maintain an
asset’s compliance