Good Laboratory Practice (GLP) Scientific Support

This pharmaceutical manufacturer is contracting most of the nonclinical bioanalytical phase of good laboratory practice (GLP) studies at contract research organizations (CROs). Because of the number of studies involved, its study monitors were not able to provide the attention required to the bioanalytical data and reports. Quality Assurance Consultancy was hired to provide this service…. Read more »

Standard Operating Procedure (SOP) Development

The Department of Pharmacology of this University had used the services of Quality Assurance Consultancy for Good Laboratory Practices (GLP) Training for several consecutive years. When the Department of Cardiology of the same University decided that they needed to establish a GLP program for the safety studies they were planning with devices, the successful training… Read more »

Bioanalytical Audits, Support and Training

Bioanalytical Audits Quality Assurance Consultancy performed an independent bioanalytical audit of the bioanalytical data and bioanalytical phase report of scores of animal studies for this pharmaceutical drug sponsor company. The LC/MS bioanalyses had been performed at four separate laboratories. The review was performed directly on the analytical electronic data acquired using Analyst, as well as… Read more »

Good Laboratory Practices (GLP) Training

Quality Assurance Consultancy good laboratory practices (GLP) trainers have conducted hundreds of GLP training seminars in numerous settings. They include the following: Training in the U.S. Environmental Protection Agency (GLP) to a university professor and his research team at his research laboratory to allow the conduct of three studies over a three-year period with the… Read more »

Standard Operating Procedures (SOP) Development Case Study

This company had decided to conduct all product chemistry studies for physical and chemical properties of their pesticides in house. To implement this decision, the analytical laboratory had to be upgraded to abide by the good laboratory practices (GLP). With several personnel in the laboratory familiar with the GLP requirements, the laboratory decided to contract… Read more »

Support of Existing Quality Assurance Units (QAU)

The size of the Registration Quality Assurance (RQA) unit of this pharmaceutical company provides all quality assurance (QA)requirement for the “steady-state” level of workload. Occasionally, pivotal clinical studies are completed simultaneously just before submission for an investigational new drug (IND) or new drug application (NDA). Typically, the bioanalytical laboratory is required to analyze thousands of… Read more »

Independent Quality Assurance Units (QAUs)

Outsourcing of the Quality Assurance Unit (QAU) Function Case Study 1 This analytical laboratory is a unit of an S&P 500 industrial manufacturer. Management prefers to outsource select operations and contracted Quality Assurance Consultancy to operate as the laboratory QAU, operating under the U.S. Environmental Protection Agency (EPA) good laboratory practices (GLP), American Industrial Hygiene… Read more »

Establishment of Good Laboratory Practice (GLP) Programs

This research company had developed recombinant plants that expressed a beneficial protein (plus one or more marker proteins). Characterization and other studies were required to be submitted for marketing approval. These studies were supposed to be conducted under Good Laboratory Practices (GLP), but no one in the company had experience with these laboratory regulations. Quality… Read more »