A customized strategy for multiple drug manufacturing facility. It may be helpful for others who have interest or pursuing towards developing strategies for compliance.

1. Zinc Sulphate Dispersible Tablets 20 mg
WHO Pre-Qualification
April 21, 2025
Centre for Quality Sciences

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
250421-CAR-011D-CQS
Roohi B. Obaid
Monday, the 21st
Apr 2025
Zinc Sulphate Dispersible Tablets 20 mg – WHO Pre-Qualification
PRIME OBJECTIVES:
1. To conduct experiments and develop formulation of Zinc Sulphate Dispersible Tablet 20
mg by dry mixing method.
2. Re-designing one of the existing oral dosage form manufacturing suite to comply stringent
GMP standards in its highest possible spirit.
3. Enhancement of quality with modern and emerging GMP expectations narrated in GMP
Guide of both WHO and PIC/S for the associated services and practices is another objective.
Multi-layer cross-linked project. The design is comprised of 6 different sequential phases where
shadow of parallel working consistent to preserve the objectives is advised in the interest of time and
smart progress.
Phase Zero: Initiate discussions, site tour, reviews and defining of objectives.
Phase 1: Project initialization and planning
Phase 2: Supplier qualification and raw material strategy
Phase 3: Product development
Phase 4: Facility upgrade and GMP readiness
Phase 5: Regulatory submissions and WHO PQ
Each delay will increase overall lead time

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
PHASE 1: Project Initialization and Planning
1.1 Appoint a Cross-functional Core Team (CCT)
 CCT includes:
o QA
o QC
o R&D
o RA
o Engineering
o Procurement
o Finance
o Manufacturing
Timeline: One Week
1.2 Develop a comprehensive project charter:
 Conduct a series of meetings of CCT with CQS Consultants to define, discuss and finalize
the scope, objectives, milestones, success criteria in black and white.
Timeline: Two Weeks
1.3 Manufacturing suites, gap assessment
 Activity includes:
o HVAC status
o Material/personnel flow
o Area classification
o Utility mapping
Timeline: Two Weeks
PHASE 2: Supplier Qualification & Raw Material Strategy
2.1 Identify Suppliers and its Qualification
 WHO approved supplier for API
 ICH compliant API suppliers as alternative
 Qualification of excipient suppliers

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
Timeline: Two Weeks
2.2 Pursue for Drug Master Files (DMF)
Timeline: Two Weeks
2.3 Supplier audits & contract finalization
 Verify GMP, CoA authenticity, traceability
 Write and get approved the agreement for consistency and quality. Develop some indicators
in agreement for the intended purpose.
Timeline: Six Weeks
PHASE 3: Product Development
3.1 Literature review, QTPP establishment & CQA identification
 Reference materials, known guidance
 Define critical quality attributes (CQAs) for the product
Timeline: One Week
3.2 Pre-formulation & risk assessment (ICH Q Guidance)
 Design of studies for compatibility and stability
 Define CPPs and establish CQAs using ICH Q9
Timeline: One Week
3.3 Formula and process development
 Dry mixing process trials
 In-process controls:

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
o Hardness
o Friability
o Dispersion time
Timeline: Four Weeks
3.4 Manufacture Exhibit Batches (2 pilot & 1 lab scale batches)
 With full GMP documentation
Timeline: Three Weeks
3.5 Analytical Methods Validation
Timeline: Three Weeks
3.6 Stability Studies (ICH Q Guidance)
 Minimum 6 months accelerated data required for submission
Timeline: Start at Week XXX
PHASE 4: Facility Upgrade & GMP Readiness
4.1 Renovation of manufacturing suite & its qualification
 Defining flows
 HVAC validation
 Utilities adjustment & qualification
 Cross-contamination control
Timeline: 16 Weeks
4.2 Equipment selection, relocation/procurement, installation, IQ/OQ

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
 Blender, compression machine, in-process testing etc.
Timeline: 16 Weeks
4.3 Process Validation Move
 Stage 1 & 2, Process (design and qualification)
Timeline: Two Weeks
4.4 Personnel Specific Trainings & SOP implementation
 Batch documentation, data integrity, hygiene, cleaning validation etc.
Timeline: Six Weeks
PHASE 5: Regulatory Submission & WHO PQ
5.1 Compile Common Technical Document (CTD)
 Fill the requisites and justify request for BE waiver
Timeline: Six Weeks
5.2 Get independent review and submit to WHO PQP
Timeline: Two Weeks
5.3 Respond to WHO queries (if any)
 Within 30 days per round
Timeline: Immediate but not more than Four Weeks

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
5.4 WHO site inspection (upon acceptance)
 Prepare for audit readiness (Quality Management Review)
 Expected: After 3–6 months of submission

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Certainty of Qualification & Advancing the Quality
CQS Property XXX (2025) - 832-C, Block-2, PECHS, Karachi
DELAY FINANCIAL IMPACT FRAMEWORK
For each week of delay beyond plan:
 Manpower and Overhead cost
 Loss of time in terms of expected benefits
 Increase of Regulatory reassessment risk and cost
Project Duration: 103 Weeks (Approx. 26 months)
ID Task Description Start
(W)
Time
(W)
Cross
Reliance
1 Appoint a Cross-functional Core Team (CCT) 1 -
2 Develop a comprehensive project charter 2 -
3 Manufacturing suites, gap assessment 2 1
4 Identify Suppliers and its Qualification 2 2
5 Pursue for Drug Master Files (DMF) 2 4
6 Supplier audits & contract finalization 6 5
7 Literature review, QTPP establishment & CQA identification 1 2
8 Pre-formulation & risk assessment (ICH Q Guidance) 1 7
9 Formula & Process Development 4 8
10 Manufacture Exhibit Batches (2 pilot & 1 lab scale batches) 3 9
11 Analytical Methods Validation 3 9
12 Stability Studies (ICH Q Guidance) - Start Start 10, 11
13 Renovation of manufacturing suite & its qualification 16 3
14 Equipment selection, relocation/procurement, installation, IQ/OQ 16 3
15 Process Validation Move 2 10, 13
16 Personnel Specific Trainings & SOP implementation 6 14
17 Compile Common Technical Document (CTD) 6 12, 15
18 Get independent review and submit to WHO PQP 2 17
19 Respond to WHO queries (if any) 4 18
20 WHO site inspection (upon acceptance) 24 14, 15, 16
W: Week
Note: Total 103 weeks required in which 24 weeks is waiting period and remaining 79 weeks are working.
This 79 working weeks will be relying on simultaneous working at various task descriptions of the project. It is
one and a half to two year project subject to extensive supervision and trainings on fundamental
affairs of GMP and quality to execute the said task.