|
|
Example Projects
Example Projects
|
Compliance:
- Assessed Manufacturer’s Compliance with Quality Agreement:
Reviewed the firm’s quality system and actual practices against a Quality Agreement reporting areas where they were not in compliance with the Agreement. Made recommendations to management for modify certain appropriate aspects of the Quality Agreement and take corrective actions to improve quality system.
- Conducted a Mock Pre-Approval Inspection:
Following, a comprehensive PAI checklist, a Systems Approach inspection was performed focusing primarily on the product documentation vs the CMC submission data. Documents reviewed included batch records, process validation protocols, cleaning validations, stability data, analytical methods validation, and shipping studies.
- cGMP Compliance Audit:
Following a Systems Approach, reviewed firm’s EIR and identified “weak spots” in the firm’s quality structure. Reviewed SOPs and Work Instructions and observed actual practices. Conducted employee interviews and toured facility. Reviewed batch records, supply chain and external audits, laboratory records, internal audits, testing protocols, warehouse procedures, traceability of materials, computer validations, maintenance procedures, training systems, complaint systems, and records that apply to the particular vendor. Prepared written report of observations.
Process Improvement Project Examples:
- Quality System Improvement Project:
- Objective:
Determine why numerous deviations occurred over a two year period and recommend actions to reduce the frequency of deviations. All deviations were reviewed, categorized, and rank ordered. The percentage of deviations occurring in each of the quality system categories was determined. An objective assessment was performed on the documented root causes and CAPAs.
- Result:
QA staff was re-trained on how to conduct investigations and identify root causes and CAPAs. SOPs related to the root causes were updated to improve clarity and personnel were trained. Client reported that this approach was effective in reducing deviations over the next year.
- Clinical Supply Gap Analysis (mid-sized biotech company).
- Objective:
Identify an approach for building a robust clinical supply operation.
- Approach:
Evaluated all operational aspects of clinical supply manufacturing and packaging, including personnel interviews, evaluation of all Standard Operating Procedures, and discussions with management, including Executive Management. Evaluated communications flow and methods of managing projects. Interviewed internal customers and suppliers. Identified inefficiency and source of potential quality issues. Prepared audit observations and recommended actions. Prepared gap analysis report identifying current state, desired state, and recommendations. Assisted with developing short-term and long-term implementation plan, which became the basis for a newly formed organization.
- Results:
The firm followed the implementation plan resulting in the design and construction of a facility and established a fully-staffed clinical supply packaging, labeling and distribution facility.
- Standard Operating Procedure Restructuring Project: (mid-size virtual pharmaceutical company)
- Objective:
Revamp all product development SOPs to define a more comprehensive set of standards to facilitate cGMP compliance, reduce overall number of procedures, improve clarity, and assure integration of procedures with Product Development, Clinical Manufacturing, QA, Clinical, and Regulatory.
- Approach:
Reviewed all SOPs, developed process map defining current state with input from each function, identified gaps, prioritized procedures needing revision and identified new procedures that were required. Revised and developed SOPs with ongoing input from key functions.
- Results:
SOPs were fully integrated, clearly written, covering all aspects of cGMP or GCP required for the organization with ~15% reduction in overall number of SOPs.
Outsourcing Project Example:
- Strategic Outsourcing Project: (virtual pharmaceutical company)
- Objective:
Identify at least 2 contract manufacturers to manufacture and primary package 12 batches of a semi-solid vaginal gel. Establish contracts and manage all aspects of the project at 2 sites (to assure redundancy) with rapid turnaround to assure ready supply of PII product.
- Approach:
Identified multiple options based on technical capability and capacity; evaluated risks/benefits of each site. For 2 sites, scheduled QA inspections; wrote RFP, negotiated quotes and facilitated CDA, MSA, and SOW approvals with client; assured API, raw material, and packaging component supplies; provided on-site support for process transfer; reviewed production records; provided sampling plans and instructions for sample and product shipments. Conduct project close-out and Lessons Learned.
- Result:
Process was transferred and multiple batches manufactured in time to meet client deliverable date.
- Project Management Example:
- Objective:
As Manufacturing Project Manager, initiate the start-up of Phase I manufacturing project.
- Approach:
Led manufacturing staff to prepare for project the project. A timeline was developed; ancillary equipment was purchased; major process equipment was qualified; excipients and packaging components were purchased, tested, and release; API was tested and released; analytical methods were developed for API and detergent residue swab testing to support cleaning verification; master production records were written; and personnel were trained. Authored the initial draft of Technology Transfer Protocol to assure that transfer activities were well-documented and agreed to cross-functionally.
- Result:
The project was successfully transferred and started earlier than planned.
|
|