ASQ DefinitionsAssurance: The act of giving confidence, the state of being certain or the act of making certain. Quality assurance: The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. FDA DefinitionValidation: Establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications.

Validation Master Plan
The company’s overall policy, intentions and approach to validation, including the validation of production processes, cleaning methods, analytical test methods and computerized systems, should be established in the Validation Master Plan.

Site Validation Master Plan versus:
 Project Master Plan  Cleaning Validation Master Plan  Process Validation Master Plan  Computer System Validation Master Plan

Site Validation Master Plan
What  Where  Why  Who  How Format  When Sched.

Purpose Scope Policy & Rationale Responsibilities Doc. Content & Prioritization &

Site Validation Master Plan- Scope
 

 

Facilities Lab Equipment Laboratory Methods Water & Steam HVAC Gas Systems

   

Mfg. Equipment Process Cleaning Computer Systems

Equipment Qualification
       

General Pre-Qualification Activities Qualification Activities Protocol Preparation Installation, Operational & Performance Qualification Acceptance Criteria Summary Report Re-qualification

Test instrumentation and simple equipment (pH meters, viscometers, scales) will be qualified via a procedure instead of a protocol. The procedure approach is applicable to equipment that:  Employs commonly used technology.  Is easily installed.  Is routinely (minimum daily) checked for accuracy prior to use.  Does not require specialized operating skills and expertise.

The definition of what constitutes a change to lab equipment that may require requalification includes the following: •Failure of test results •Relocation- equipment unplugged and moved within a room, between rooms, between buildings •Major component changes or modifications, including software changes

Planning Step # 1: Inventory Existing Work
Equipment List & Schedule:
ID Equipment Target Qualification Completion Date 1Q-2008 3Q-2008 N/A Completed Qualification Status --Calibrated Qualified

1-01 1-02 L 19 L 19

Water HPLC Shimadzu Spectrophotometer Temp. Recorder Viscosimeter

Product Contact List
Product Description: ID Alpha A Suspension.doc Location Equip. Capacity Description MIXING TANKS 100 L 400 L NA

MT-1 Lee Tank MT-2 Lee Tank PM-1 Hobart

Rm. 21 Rm. 21 Portable


FDA 483 Observations

Not all manufacturing ISO Class [removed] rooms, Biological Safety Cabinets and manufacturing equipment have documentation of cleaning validations. No validation studies were conducted to support cleaning of the [removed].

Product/Equipment Matrix
Equip. ID Name Prod. Name Apha 1 Apha 2 Beta R Beta S Prod. Code Batch Size X X X X X X X X X X X 3001 Tank-1 3002 Tank-2 3003 3004 3005 Pump-1 Pump-2 Mixer-1


Planning Step # 2: Prioritization
Priority 1 Products: Product Mfg. Code Name on Site Apha 1 Apha 2 Beta R Beta S DDGH GANN KKLV KKLC X X X X Pkg. Targeted Lab. on Completion Tests Site Date 1,2 1,2 1,2 1,2 R/S R/S R/S R/S 2Q 2008 3Q 2008 1Q 2009 4Q 2009

Planning Steps 3 & 4: Establish a Timeline & Estimate Resources
Category Totals No. Req. Val. 89 60 178 65 65 630 (A) Pers. Req. 2 1 4 2.25 1 -(B) Time Req. (Yrs.) 2.5 9.0 3.5 8.0 7.25 9 (A) X (B) = Total Time Required (Man-years) 5 9.0 14.0 18.0 7.25 77.5

Lab Equip. Methods Mfg. & Pkg. Equip. Process Cleaning Sub-Totals:

111 124 195 65 65 836

2Q 2008










Gas 6 mo. HVAC & LFUs 2.0 yrs. Lab Equip. Qual. 1.5 yrs. LOC Methods Validation 3.0 yrs. Cleaning Methods yr. LOC Equipment 1.5 yrs. All Other Equipment 2.0 yrs. LOC Process Validation 3.0 yrs. LOC Cleaning Validation 3.75 yrs. Total Equipment Qualification 3.5 yrs. All Other Process Validation 5.0 yrs. All Other Cleaning Validation 4.25 yrs. Total Process Validation 8.0 yrs. Total Cleaning Validation 8.0 yrs. All Other Methods 6.0 yrs. . Total Methods Validation 9.0 yrs.

LOC Transfer Project All Other Validation

Site Validation Master Plan Value

The Site Validation Master Plan provides clarity, and it enables the validation manager to communicate the workload, capacity constraints and justify the need for resources. It facilitates effective management and the best performance.

Planning Step # 6: Repeat Steps 1-5
FDA 483 Observation:

The firm has a protocol for the qualification of solutions used in Manufacturing. This protocol has been effective since 21 Dec 2004. To date only 2 of the approximately 50 materials used in either the manufacture of products or for cleaning/disinfection have been qualified.

Six Steps to Planning:
2. 3. 4. 5. 6.


Inventory all existing and upcoming work. Prioritize. Establish a timeline. Estimate the resources needed. Communicate to upper management for involvement, commitment and resources. Repeat Steps 1-5 on a routine basis.

Process Optimization


1. Identify the Task
Document Changes
Protocol Approval (Signed) Protocol Execution (Signed) Summary Report Approval (Signed)





2. Concentrate the Work

3. Form Partnerships

4. Define Performance
Responsibilities Matrix:
Activity Planning Define Priorities: 1) Analytical Methods 2) Laboratory Equipment 3) Facilities / Utilities 4) Production Equipment 5) Process Val. User / Owner QA

5. Training

The greatest benefit of training comes not from learning something new, but from doing better what we already know.

Five Steps to Optimization
1. 2. 3. 4. 5.

Identify the tasks. Concentrate the work. Define performance. Form partnerships. Build continuous learning and teaching.

Constraints vs. Performance

Quality Cost Time

Look at the Big Picture

Periodic review applying an holistic approach to quality systems.

Process Optimization

 

Incorporate steps to optimize individual processes (quality system). Look at the constraints. Periodically review applying an holistic approach to quality systems.

 Regulatory

Requirement  Assures Quality  Good Economics


 

ASTM E 2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment ICH Q9 Quality Risk Handbook Pharmaceutical cGMPs for the 21st Century—A RiskBased Approach FDA Guide to Inspections of Quality Systems- August 1999 The Gold Sheet- January 2008: “Quality Systems No Longer Theoretical as Industry Begins Implementing Concepts”

Lee Menszak Consulting, Inc. 845-300-1730

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