Pharmaceutical Development – QBit QA Consulting

Pharmaceutical Development

QBit QA Consulting specializes in providing expert guidance and solutions throughout the entire pharmaceutical development lifecycle. With a deep understanding of the regulatory landscape, market dynamics, and the complexities of drug development, we partner with pharmaceutical companies to bring innovative treatments to market with efficiency and compliance.

DRUG DEVELOPMENT PROCESS

Discovery and Development – Research for a new drug begins in the laboratory.
Preclinical Research – Drugs undergo laboratory and animal testing to answer basic questions about safety.
Clinical Research – Drugs are tested on people to make sure they are safe and effective.
FDA Review – FDA review teams thoroughly examine all of the submitted data related to the drug and make a decision to approve or not to approve.
FDA Post-Market Safety Monitoring – FDA monitors all drug safety once products are available for use by the public.

DOSAGE FORMS & ROUTE OF ADMINISTRATION

Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components (excipients), configured in a particular way and apportioned into a specific dose.
Dosage forms vary depending on the method and route of administration, which can include many types of liquid, solid, and semisolid forms. Common dosage forms include tablets, capsules, syrups, creams, and injectables.

A combination drug (or fixed-dose combination; FDC) is a product that contains more than one active ingredient.

The route of administration (ROA) for drug delivery depends on the dosage form of the substance. Different dosage forms may be available for a particular drug, especially if certain conditions restrict the ROA. A specific dosage form may also be required due to issues such as chemical stability or pharmacokinetic properties.

CHOOSING A DOSAGE FORM

CHEMISTRY MANUFACTURING & CONTROLS

Chemistry Manufacturing & Controls (CMC) is an essential part of the Drug Development Process. CMC is a term used when drug developers define their investigative drug substance, establish manufacturing methods for that drug, and develop a strategy for controlling the quality and stability of the product from early phases through post-approval production.

QUALITY By DESIGN (QbD)

QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. The approach aligns with the eCTD format, covering the elements required for a successful regulatory submission. By using the QbD approach, development can be accelerated and resources can be used more effectively.

Elements of Pharmaceutical Development

Quality Target Profile (QTP)

The quality target product profile forms the basis of design for the development of the product. Considerations for the quality target product profile could include:

Intended use in clinical setting, route of administration, dosage form, delivery systems;
Dosage strength(s);
Container closure system;
Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics (e.g., dissolution, aerodynamic performance) appropriate to the drug product dosage form being developed;
Drug product quality criteria (e.g., sterility, purity, stability and drug release) appropriate for the intended marketed product.

Critical Quality Attributes (CQA)

A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are generally associated with the drug substance, excipients, intermediates (in-process materials) and drug product.

Risk Assessment

Risk assessment is a valuable science-based process used in quality risk management that can aid in identifying which material attributes and process parameters potentially have an effect on product CQAs. Risk assessment is typically performed early in the pharmaceutical development process and is repeated as more information becomes available and greater knowledge is obtained.

Design Space

The relationship between the process inputs (material attributes and process parameters) and the critical quality attributes can be described in the design space.

Control Strategy

A control strategy is designed to ensure that a product of required quality will be produced consistently. The elements of the control strategy should describe and justify how in-process controls and the controls of input materials (drug substance and excipients), intermediates (in-process materials), container closure system, and drug products contribute to the final product quality. These controls should be based on product, formulation and process understanding and should include, at a minimum, control of the critical process parameters and material attributes.

Product Lifecycle Management and Continual Improvement

Throughout the product lifecycle, companies have opportunities to evaluate innovative approaches to improve product quality. Process performance can be monitored to ensure that it is working as anticipated to deliver product quality attributes as predicted by the design space. This monitoring could include trend analysis of the manufacturing process as additional experience is gained during routine manufacture. For certain design spaces using mathematical models, periodic maintenance could be useful to ensure the model’s performance. The model maintenance is an example of activity that can be managed within a company‘s own internal quality system provided the design space is unchanged. Expansion, reduction or redefinition of the design space could be desired upon gaining additional process knowledge. Change of design space is subject to regional requirements.