Pharmaceutical Quality Control

• Quality Control ensures pharmaceutical products meet required standards

Definitions of Quality

• One definition is the features a product has
• Another definition relates to the absence of defects
• Production perspective defines it as the degree to which a product meets design specifications and customer expectations
• Value perspective sees it as providing customer value that meets or exceeds expectations affordably
• Quality considers waste reduction impacting environment and society while maintaining customer satisfaction
• Quality is the degree an object satisfies requirements
• Quality is determined by comparing characteristics to requirements
• High quality results when characteristics meet requirements
• Low quality results when characteristics don't meet requirements
• Quality is an outcome within a quality management system

Key Elements of Total Quality Management (TQM)

• Customer focus is a key element
• Employee involvement is a key element
• Continuous improvement is a key element

Reasons for Advancing Quality

• Complex and potent medicines necessitate it
• High research, development, and production costs demand it
• Highly regulated processes require in-process control for quality
• Consumers expect and have the right to high-quality products

Drug Characteristics Meeting Requirements

• Identity guarantees the correct active ingredient is present
• Purity ensures the drug isn't contaminated
• Potency confirms the correct amount of active ingredients, 100±2% for raw materials, 100±10% for finished products
• Uniformity provides consistency in color, shape, and size
• Bioavailability ensures consistent drug entry into the bloodstream for predictable therapeutic effects
• Bioavailability can vary among manufacturers
• Stability guarantees drug activity throughout its labeled lifespan

Financial Growth in the Pharmaceutical Industry

• Pfizer reported a 92% operational revenue growth, reaching $81.3 billion in 2021 versus $41.7 billion in 2020
• AstraZeneca's total revenue in 2021 was $37.42 billion, including COVID-19 vaccine revenues, a 41% increase from $26.62 billion in 2020

Fundamental Features of a Quality System

• A quality policy defines objectives for pharmaceutical manufacturing facilities
• Resources include materials, equipment, and personnel
• Documentation encompasses procedures and standards
• An audit process ensures procedure compliance

Quality Management (TQM)

• TQM oversees activities and tasks to maintain excellence
• TQM includes quality planning, assurance, control, and improvement
• GQMC directs efforts towards the system's aim

Deming Cycle

• Used to test information before decisions
• The four steps are Plan-Do-Check-Act

Quality Standards

• The International Organization for Standardization (ISO) created these standards in 1987
• The ISO 9000:1987 series covers designing, production, and service delivery across industries

British Standards Institution (BSI)

• BSI creates standards across various industries
• BSI's codes cover technical subjects to quality requirements
• Founded in 1901 in the UK as the Engineering Standards Committee, and operates in over 140 countries
• Aims include promoting trade, reducing waste, and protecting consumers

Food and Drug Administration (FDA)

• The FDA regulates foods, drugs, vaccines, biologics, medical devices, and cosmetics
• The FDA operates as a US Department of Health and Human Services agency

European Medicines Agency (EMEA)

• Formerly the European Agency for the Evaluation of Medicinal Products
• EMEA harmonizes national medicine regulatory body work
• The EU is the source of ~1/3 of new drugs

Medicines and Healthcare products Regulatory Agency (MHRA)

• The MHRA ensures safe use of medicines and devices
• The MHRA functions as the UK government agency

World Health Organization (WHO)

• WHO coordinates international public health
• The WHO is a specialized UN agency

The International Conference on Harmonization (ICH)

• The ICH harmonizes pharmaceutical regulations across Europe, Japan, and the United States
• The ICH's purpose is to reduce duplicated testing during R&D, harmonize technical guidelines, and requirements for product registration

Regulatory and Safety Authorities

• Egyptian Drug Authority (EDA)
• Egyptian National food safety Authority (NFSA)

Departments in Pharmaceutical Companies

• Warehouse (W/H)
• Research and Development (R & D)
• Quality Control (QC) [IPC, ACU]
• Production
• Engineering Department
• Quality Assurance (QA)
• Supply chain
• Planning
• Regulatory Affairs
• Pharmacovigilance
• HR, Financial, Marketing, etc

Material Flow in Pharmaceutical Manufacturing:

• Purchase -> Warehouse -> Warehouse quarantine -> Sampling -> QC testing
• QC testing results in product being ->Released or Rejected
• If released material goes through Weighting room -> Production -> Finished product

•  If rejected material is either: Returned/Reprocessed/Destroyed
  

Raw Materials

• Raw Materials are all materials used with manufacturing a finished bulk product
• Raw Materials can be categorized into APIs, inactive ingredients/excipients, and packaging materials

Active Pharmaceutical Ingredient (API)

• APIs are substances intended to be used in the manufacture of a pharmaceutical dosage form
• APIs furnish pharmacological activity and affect body structure/function

Inactive Ingredients or Excipients

• Excipients are also called inactive ingredients or drug carriers
• Excipients bring bulkiness, stability, facilitating absorption and preventing drugs denaturation
• Gelatin capsules are considered excipients, not primary packaging

Packaging Raw Materials

• Primary packaging directly contacts the product (e.g., glass, aluminum, PVC)
• Secondary packaging is outside primary packaging (e.g., boxes, pamphlets)

Types of Pharmaceutical Products

• Intermediate product is Partly processed product requiring further manufacturing steps
• Bulk product is Any product post processing, but prior to final packaging
• Finished product is A finished dosage form that has undergone all stages of manufacture, including packaging and labeling

Pharmaceutical Terms

• Packaging includes filling and labeling a bulk product to get to a finished product
• The filling of a sterile product isn't considered part of normal packaging.
• Reference substances are essential for identification, purity assessment & pharmaceutical assays
• A batch is a defined and homogenous quantity of starting/packaging material or product processed
• A batch size is either fixed or the amount during a time interval
• The batch size is determined by autoclave capacity if it is a terminally sterilized batch

Batch Definitions

• Batch number uniquely identifies a batch via numbers and/or letters
• Batch records document the history of each product batch
• Consignment defines the quantity of a pharmaceutical supplied at one time per request.
• Manufacturer is A company with operations such as production, packaging, repackaging, labelling and re-labelling of pharmaceuticals.
• Airlock is enclosed space between two rooms, to control airflow