Situation:

A customer requested a full GMP audit of a third-party contract manufacturing facility that was going to manufacture clinical material for them.

Our Solution:

identified, communicated with, and coordinated on behalf of the client, and conducted a full cGMP audit. The audit evaluated their system's compliance with FDA 21 CFR Parts 11, 50, 54, 56, 210, 211, 312, 314, and ICH Q7A, E2A, and E6. In addition, the audit included a physical review of their facility, including the warehouse, labs, pest control, manufacturing, and packaging areas. After the audit, a series of observations were addressed by the facility, and they were approved to manufacture the clinical trial material.

Situation:

A customer requested an audit during the blister packaging process of their clinical trial material at a third-party contract manufacturing facility.

Our Solution:

Coordinated with the client’s technical, quality, and manufacturing functions to be present during the complete blister packaging process. During this time, QRS performed a process vs. procedure challenge related to the process by reviewing the procedures directly with the operations step by step. This challenge produced a lot of improvements to the facility process and, at the same time, guaranteed that QRS customer product was packaged following all cGMP and was in control. All recommendations presented were accepted, and improvements were made. This is a good example of how the type of audits performed by QRS benefit both the customer and the audited company.

Situation:

A stakeholder with a focus on the generic market wanted to develop a niche prostaglandin product indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension.

Our Solution:

Identified, communicated and coordinated on behalf of the client with several early stage developers of highly complex, high valued API. Conducted cGMP audits of shortlisted vendors, assessed their capability and capacity to deliver drug substance on time for formulation development and guided preparation of DMF with adequacy of information for drug product development. Assisted client in identifying a contract developer and manufacturer of sterile formula. Overseen technology transfer, validation batches, quality control, stability studies, quality assurance and regulatory compliance aspects during the development cycle. Facilitated preparation of ANDA for timely submission.

Situation:

A stakeholder with more than 100 Rx and OTC products in his basket faced severe capacity constraints to introduce new products and wanted to transfer high volume, low margin products to a CMO.

Our Solution:

Coordinated with the client’s technical, quality and manufacturing functions to prepare technology transfer packages of eight different formulated products. Searched, identified and shortlisted suitable GMP CMOs and generated business proposals for consideration of the client. Accompanied the client core management team to short listed CMOs for the first hand evaluation and selection of CMO partner. Overseen technology transfer, validation batches, product quality and comparability protocols including stability studies. Assisted the client for preparation and submission of post approval changes to USFDA.

Situation:

A stakeholder of generic Rx products with in-house API process R&D unit acquired aged high volume API facility for $80 MM from a leading multinational, which failed to produce new generic APIs cost effectively.

Our Solution:

It was engaged to identify problems associated with in-house R&D processes and overcome difficulties encountered in the scaling-up of these processes in the newly acquired facility. Introduced the concept of process engineering and statistical design of experiments in R&D to acquire and optimize kinetics data for key synthetic chemistry steps along with other Physico-chemical data such as solubility curve etc. Defined and obtained process data for product isolation, purification, and drying processes at the R&D scale to maximize throughput from available filtration and drying equipment in the plant. Conducted process mapping to identify bottlenecks in-plant facility and upgraded select equipment/utilities technologies to achieve the desired throughput. 

Situation

A small global pharmaceutical company intended to use its internal quality assurance staff to conduct various GCP audits for a Phase 3 project in preparation for FDA and MHRA submissions.

THE RESPONSE

Projects with aggressive timelines may face execution and quality issues.

THE OUTCOMES

QualRS was able to provide both effective and efficient auditing services as well as robust metrics on audit trends from generated audit reports by leveraging proprietary SOPs and metric tools.

ADVANTAGES OF QUALRS

Third-party FDA/MHRA inspection readiness audits are especially beneficial to clients who lack the capacity or expertise to conduct an audit themselves or want an unbiased audit.

QualRS is an independent global auditing firm that critically examines a client's current GCP processes and prepares clients for future FDA/EMEA or other regulatory agency inspections. QualRS performed 21 investigator site audits, 2 PV audits, 2 mock FDA/EMEA sponsor audits, and 4 document audits for the client in this case.

Auditors at QualRS have an average of 26 years of industry experience and 18 years of GxP auditing experience. As a result, QualRS is a market leader in quality assurance.

Respondents to a survey indicated that QualRS' auditor experience was its most valuable resource.

Auditors at QualRS are well-versed in industry best practices and subject matter experts in their respective auditing fields.