Introduction: Consultant Engagement and Initial Training (Duration: 0.5 Month)

Introductory Tasks

1.1 Initial Consultation and Project Kick-off

Task: Schedule Initial Consultation

• Description: Arrange a meeting to discuss project scope, objectives, and timelines.
• Documentation: Project plan and meeting agenda.
• Meeting: Initial consultation meeting.

Task: Conduct Gap Analysis

• Description: Analyze existing practices against ISO 22716 requirements to identify gaps.
• Documentation: Gap analysis report.
• Meeting: Review findings with the consultant.

Task: Develop Training Plan

• Description: Create a comprehensive training plan on ISO 22716 requirements.
• Documentation: Training plan document.
• Meeting: Finalize the plan with the consultant.

Section 1: General Requirements (Duration: 0.5 Month)

2.1 Quality Management System (QMS)

Task: Establish QMS

• Description: Develop a QMS tailored to ISO 22716 requirements.
• Documentation: QMS manual.
• Meeting: Review session with stakeholders.

2.2 Roles and Responsibilities

Task: Define Roles and Responsibilities

• Description: Identify and document personnel responsibilities for GMP compliance.
• Documentation: Organizational chart and role descriptions.
• Meeting: Confirmation meeting with management.

Section 2: Premises and Equipment (Duration: 1 Month)

3.1 Premises Layout and Design

Task: Review and Optimize Layout

• Description: Assess facility layout for compliance with GMP requirements.
• Documentation: Facility layout plan.
• Meeting: Site walkthrough with consultant.

3.2 Equipment Management

Task: Develop Equipment Maintenance Plan

• Description: Create procedures for equipment maintenance, calibration, and cleaning.
• Documentation: Maintenance plan.
• Meeting: Training on equipment protocols.

Section 3: Raw Materials and Packaging(Duration: 1.5 Months)

4.1 Supplier Management

Task: Evaluate and Approve Suppliers

• Description: Establish criteria for supplier evaluation and approval.
• Documentation: Approved supplier list.
• Meeting: Review supplier audits with the consultant.

4.2 Raw Material Control

Task: Implement Material Receipt Procedures

• Description: Develop procedures for the inspection and storage of raw materials.
• Documentation: Material control procedures.
• Meeting: Training sessions for staff.

Section 4: Production and Quality Control)(Duration: 2 Months)

5.1 Production Processes

Task: Document Production Procedures

• Description: Develop standard operating procedures (SOPs) for production.
• Documentation: SOPs for all processes.
• Meeting: Review production SOPs with the consultant.

5.2 Batch Records

Task: Implement Batch Record System

• Description: Establish a system to document and track production batches.
• Documentation: Batch record templates.
• Meeting: Staff training on record-keeping.

5.3 Quality Control

Task: Develop Quality Testing Protocols

• Description: Create protocols for testing raw materials, in-process products, and finished goods.
• Documentation: Testing protocols and logs.
• Meeting: Training with the quality team.

Section 5: Storage and Distribution (Duration: 1 Month)

6.1 Storage Conditions

Task: Define Storage Requirements

• Description: Identify appropriate storage conditions for raw materials and products.
• Documentation: Storage guidelines.
• Meeting: Staff training on storage protocols.

6.2 Distribution Controls

Task: Establish Distribution Procedures

• Description: Develop procedures for product distribution, ensuring traceability and quality.
• Documentation: Distribution records.
• Meeting: Training on distribution protocols.

Section 6:Documentation and Record-Keeping (Duration: 1.5 Months)

7.1 Document Control

Task: Implement Document Control System

• Description: Develop procedures for creating, reviewing, and approving documents.
• Documentation: Document control procedures.
• Meeting: Training session on document management.

7.2 Record Retention

Task: Define Record Retention Policies

• Description: Establish retention periods for records as per GMP requirements.
• Documentation: Retention policy document.
• Meeting: Internal review with staff.

Final Assessment and Certification Preparation(Duration: 1 Month)

8.1 Pre-Assessment Audit

Task: Conduct Pre-Assessment Audit

• Description: Review implementation progress and identify gaps.
• Documentation: Pre-assessment report.
• Meeting: Consultant review of audit findings.

8.2 Certification Body Selection

Task: Select Certification Body

• Description: Research and select a suitable ISO 22716 certification body.
• Documentation: Certification body selection report.
• Meeting: Final consultation to confirm the selection.