QUALITY ASSURANCE & QUALITY CONTROL

Quality Assurance WHO

A wide-ranging concept covering all matters that individually or collectively influence the quality of a product.

Quality Assurance ISO 9000

Part of quality management focused on providing confidence that quality requirements will be fulfilled.

Quality Control ISO 9000

Part of quality management focused on fulfilling quality requirements.

Quality Control in GMP

Includes sampling, testing, documentation, and release procedures ensuring all necessary tests are done before product release.

Quality assurance

Development, quality control, production, distribution, inspections.

Quality assurance

Ensure quality in the processes by which products are developed.

Quality control

Ensure quality in products by identifying and correcting defects.

Quality assurance

managerial and ensures processes produce quality outcomes.

Quality control

focuses on the actual products and detects defects.

Quality assurance

Improve processes and test procedures so quality is built into the product.

Quality control

Identify defects after the product is developed and before release

Quality assurance

Focuses on the process used to make a product; proactive.

Quality control

Identifies and corrects defects in finished product; reactive.

Quality assurance

Prevents quality problems through planning and documentation.

Verification

An example of QA

Validation

An example of QC

Responsibility for QA

Everyone involved in developing the product is responsible.

Responsibility for QC

Usually assigned to a specific team testing for defects

QA and Quality Management System

Establishes a system and assesses its adequacy; includes audits.

QC and Tools/Equipment Issues

Finds and eliminates sources of problems through tool/equipment checks.

QA and Policy Compliance

Ensures company quality policies are followed

QA and SOPs

Identifies and prepares necessary SOPs related to quality

QA Release Responsibility

Ensures the product meets specifications before release.

QA and GMP Standards

Ensures manufacturing follows internal GMP standards.

Quality assurance

Conducts quality monitoring and audit functions.

Quality assurance

Advises operations for compliance with internal and external regulations.

Quality assurance

Handles day-to-day control of quality

Quality control

Tests incoming raw materials and packaging

Quality control

Includes in-process tests, environmental monitoring, and compliance inspections.

Quality control

Conducts required tests on finished dosage forms.

Quality control

Helps select qualified vendors through sample testing.

Quality control

Audits vendors to ensure compliance with GMP before approval.

Quality control

Tests and inspects environmental areas in manufacturing.

Modern Pharma Complexity

Caused by unique drugs/dosage forms and ethical, legal, economic considerations.

Importance of Understanding Variation

Helps all personnel identify factors affecting medicine quality.

Operations Affected by Variation

Development, manufacture, control, and marketing of pharmaceutical products.

Factors Affecting Final Quality

Multiple variables in processes, equipment, materials, and environment.

Control of Quality Variation

Processes used to monitor and manage sources of variability during manufacturing to ensure consistent product quality.

Raw Material Control

System ensuring raw materials meet required specifications through sampling, testing, documentation, and controlled release.

Requirements for Good Raw Material Specifications

Specifications must be precise, complete, and include test methods, instrument types, and sampling procedures.

Raw Material Sampling Procedure

Raw materials are sampled using standard procedures and sent to QC for testing based on written methods.

Released Raw Material Label Requirements

Sticker must include item number, material name, lot number, release date, reassay date, and QA inspector’s signature.

Raw Material Quality Assurance Monograph

A comprehensive document detailing identity, testing, specifications, and supplier information for each raw material.

Monograph Section A: Identification Data

Includes raw material name, structural formula, molecular weight, chemical names, item number, dates, signatures.

Monograph Section B: Samples

Includes safety requirements, sampling plan, sample size, container type, and preservation sample requirements.

Monograph Section C: Retest Program

Details retesting schedule and required analyses to confirm identity, strength, quality, and purity.

Raw Material Specifications: Description & Solubility

Basic physical characteristics required for identification and quality evaluation

Identity Tests in Raw Material Control

May include chemical tests, infrared absorption, UV absorption, melting range, boiling point, chromatography, etc.

Purity and Quality Tests in Raw Material Control

Tests include pH, specific rotation, ash values, water content, heavy metals, particle size, crystallinity, and degradation indicators.

Raw Material Assay

Determines strength of material, calculated on anhydrous or hydrous basis.

Microbial Limit Testing for Raw Materials

Microbial tests required especially for materials from natural sources

Monograph Section E: Test Procedures

Includes compendial (USP/NF) and non-compendial detailed procedures, reagents, equipment, and calculations.

Monograph Section F: Approved Suppliers

List of prime and approved alternative suppliers for each raw material.

Preservation Samples for Raw Materials

QA keeps samples at least twice the needed amount for all tests; must be stored for at least 7 years

Rotation of Approved Raw Materials

Oldest stock must be used first to maintain quality and stability.

Classification of Raw Materials

Active/therapeutic and inactive/inert.

In-Process Items Control (IPQA)

Ensures within-batch and batch-to-batch uniformity through monitoring of critical processing steps.

Limitations of Final Dosage Testing

Testing a few units from millions can be misleading; not representative of total production.

CGMP Limitations on Variation Control

reduces contamination and errors but does not address batch variation; IPQA must ensure uniformity.

Critical Steps in In-Process Quality Assurance

Required stages QA must check to ensure consistent product quality.

IPQA: QA Before Start-Up

Includes environmental/microbiologic control, sanitation, working formula procedures, raw materials, equipment.

IPQA: QA At Start-Up

Includes raw material processing, compounding, packaging material control, label control, and finished product control.

IPQA

Ensures final products have uniform potency, quality, and characteristics across all units.

Effectiveness Inspection

QA department must perform routine area checks to verify effectiveness of spraying frequency.

Scheduled Treatment Frequency

A designated weekly timing for applying environmental control measures after working hours.

Designated Treatment Zones

Specific locations such as floors and drains where control procedures must be applied.

Materials Needed for Treatment Procedures

Items required for environmental control activities, including application equipment, chemical formulations, and necessary protective gear.

Post-Procedure Waste Handling

Guidelines stating that any leftover materials in treatment equipment must be properly removed by the assigned personnel.

Effectiveness Verification Process

Regular checks performed to determine whether an environmental treatment program is functioning at the intended level.

Immediate Corrective Response

Required prompt action upon observing any signs of infestation or process failure.

Food Protection Requirement

Mandate to cover or remove food items during environmental treatment activities.

Fire Safety Precaution

Restriction against storing or using certain chemicals near heat sources or open flames.

Application Compliance Rule

Instruction to apply chemical treatments only in locations specified in assignment listings.

Environmental Condition Monitoring

Routine evaluation of temperature, humidity, and other factors affecting manufacturing or storage quality.

Utility System Oversight

Observation of air and water systems, including air handling units, to prevent contamination.

Personnel Activity Monitoring

Assessment of staff practices to ensure they comply with quality and hygiene standards.

Variation Control Follow-Up

Use of feedback and review mechanisms to maintain consistent product quality during manufacturing.