How to Ensure Quality in Every Molecule Through Analytical Testing

Patient expectations for safety, purity, and efficacy in their medications drive the pharmaceutical industry.  Treatment demands have grown due to chronic diseases, cancers, autoimmune disorders, and an aging population. Everyone in our industry knows someone or has a friend-of-a-friend whose health depends on the quality of their work, making scientists, analysts, and Quality Assurance (QA) & Quality Control (QC) personnel inextricably bound to do-no-harm in their work.

To meet the needs, the pharmaceutical industry has embraced the rigor of continuous quality improvement (CQI) throughout the entire drug life cycle. A critical tool of CQI is tailored analytical testing at each and every stage of drug formulation – from a promising drug molecule to pre-drug compound development to clinical trials and mass production.

 

The Journey Begins With One Molecule

Standing at the forefront of new drug life cycles are knowledgeable, smart, dedicated professional men and women with intentions to create a drug that cures or stops the ravages of disease impacting a person’s health. Scientists, quality personnel, and analysts begin with a molecule that shows therapeutic promise.

The combination of such molecules, active pharmaceutical ingredients (APIs), and their analytical testing, generates early-stage safety, identity, strength, and efficacy data to determine if the compound is a safe drug candidate for further testing and development. Analytical tests are conducted on the compound by highly trained QAs and QCs. Their responsibility is to assure:

  1. The validated testing methodology is precisely followed and appropriate to the drug.
  2. The equipment meets standards of sanitation and/or sterilization to prevent malfunctions or contamination (21 CFR 211.67(a) requirements).
  3. The data results are interpreted accurately.
  4. The results are documented in reports for the FDA and the next downstream person who continues the quality developmental work.

As a leader in API sourcing, LGM Pharma recognizes the importance of a solid start in a drug’s life cycle. We continuously update and practice current quality standards and FDA guidelines. The performance criteria including accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ), reliability, and validity are exhaustive and a core competency of LGM. Our results are trusted, making LGM the go-to strategic partner to solve problems. Our partnerships with clients balance the 3 legged stool of safety quality, regulatory requirements, and cost containment.

 

Quality and Analytical Testing

Drug impurities can rear their ugly head again in downstream processes, including transportation and storage. On-going monitoring is key to catching a problem at inception, before it moves further down the process resulting in increased costs and lost time. A robust monitoring system is one that looks at real-time measurements for:

  • raw materials (pre-kick-off)
  • in-process materials
  • equipment and processes’ functioning

Designing Quality Management and CQI practices to work within the FDA’s regulatory framework of Process Analytical Technology (PAT) is critical to successful drug development. As manufacturing processes transform raw material into higher level formulations, cGMP practices and Standard Operating Procedures (SOP) must be followed to maintain statistical process control, keeping potential products within spec limits and final product quality.

 State-of-the-art analytical testing equipment in combination with process analysis produces a ton of data. However, without sophisticated analysis and follow up, the data is meaningless. Correct data interpretation is a huge weight to be carried by a business whose primary work is not in the area of analytical and microbiological testing.

Outsourcing your testing and analysis to a company who spent years building their analytical testing muscles is a smart choice. LGM is such a company. We:

  1. understand data and have the expertise for the accurate interpretation necessary for vital decision making.
  2. provide fast and accurate results to accelerate your R&D program.
  3. support the optimization of your cGMP manufacturing process, which translates into a streamlined path to regulatory approval and a successful NDA/ANDA application.

Analytical techniques are instrumental from the beginning to the end of a drugs’ life cycle. You know it and we know it. The only difference is we chose to make these techniques one of our core competencies. By partnering with us you are choosing to focus on your core competencies.

Contact us to find out how we can support your success in bringing a drug to the market while reducing costs.

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