CHAPTER 1- Introduction to QC 1 Flashcards
-Also known as Analytical
Chemistry or Pharmaceutical
Chemistry
-Branch of chemistry which
provides information relative to
the composition of matter
Qualitative-Quantitative Chemistry
if the sample is a drug
Assay
2 Divisions of Analytical Chemistry
Qualitative and Quantitative
-composition determination
-ascertainment of impurities present in a given sample
-Answers the question: WHAT IS PRESENT IN A GIVEN SAMPLE?
Qualitative
- determination of the proportion of components in a given sample
- Answers the question: HOW MUCH IS PRESENT IN THE SAMPLE?
Quantitative
- the application of the procedures of quantitative analytical chemistry to the analysis and determination of the purity and quality of drugs and chemicals used in pharmacy,
- to the analysis of the chemical constituents found in the human body
-to the analysis of medicinal agents and their metabolites found in biological systems
Quantitative Pharmaceutical Chemistry
Totality of characteristics or features of a product that bears on its capacity to satisfy stated or implied needs
Quality
are largely interdependent and often use interchangeably but different in meaning and
purpose
Quality Assurance/ Quality Control
- sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required by their intended use
- based on PROCESS APPROACH
- done before starting a project
- proactive or preventive process to avoid defects
Quality Assurance
-part of GMP concerned with sampling, specifications, testing, organization, documentation and release procedures
-PRODUCTS BASED APPROACH
- checks deliverables if it satisfy the quality requirements and specifications of customers
- begins once the product is
manufactured
Quality Control
- Assures policies are followed inept to economic issues associated with manufacturing and distribution of product
- Cooperate with regulatory agencies and final authority for product acceptance or rejection
- Helps to identify and prepare necessary SOP’s relative to control of quality
QA Departmental Functions
To determine if operations have adequate systems, facilities & written procedures
Audit and Quality Monitoring
- Testing and acceptance of only high quality raw material, representative samples
- Monitors environmental conditions (depends on products)
- Control packaging components
QC Functions
3 Main Areas of QC
- Raw Material Quality Control (RMQC)
- in-Process Quality Control (IPQC)
- Finished Product Quality Control (FPQC)
- In compliance with Current Good Manufacturing Practice (CGMP)
- Has organizational chart/structure (to avoid conflicts in the firm)
- In recent years, the QA used to describe the overall organizational body designed to assure product quality
- Production of high standard products
Administrative Order No. 220 s. 1974
- The system minimizes or eliminates the risk of
marketing unsafe products - Guarantees conformance to regulatory requirement
- Guarantees product efficacy
- Reduce operating costs/ losses
- Produces higher employee morale
- Motivates pharmaceutical/medical professions to sell or prescribe product
Potential Benefits Derived from a QC System
Basis for accepting or rejecting the product
Standards and Specification
In a product, these must cover the following 6 points:
- Formula
- Raw Materials Specification
- Standard Operating Procedure (SOP)
- Finished Product Specifications
- Packaging Material Standard
- Testing Methods
Statement of ingredients (% age, wt)
Formula
Purity of ingredient
Raw Material Specification
- Step by step method
- Covers instructions in the production
Standard Operation Procedure (SOP)
- Purity, Efficacy, Stability
Finished Product Specifications
- Bottles, Cans, Labels
Packaging Material Standard
- Conformity to standards
- Validated methods to ensure precision and accuracy on applications
Testing Methods
4 Classification of Analysis
- Based on the sample size
- Based on the extent of determination
- Based on the nature of methods
- Based on materials used
a. Ultra-micro: < 1 mg
b. Micro: 1mg - 10mg
c. Semi-micro: 10mg - 100mg
d. Macro: 100mg - 1g
Based on the sample size
a. Proximate
b. Ultimate
Based on the extent of determination
Based on the extent of determination
- total amount of class or group of active plant principles in a given sample
Proximate
Based on the extent of determination
- amount of a specific compartment/ single chemical species present in the sample
Ultimate
a. Classical
b. Instrumentation
c. . Miscellaneous/ Specific Method
Based on the extent of determination
Based on the extent of determination
- aka General/ Chemical
eg. Titrimetric Analysis, Gravimetric
Classical
Based on the extent of determination
- Based on specific physical or chemical properties of the analyte; more accurate analysis
eg. Spectrophotometry, Polarimetry, Chromatography
Instrumentation
Based on the extent of determination
- Involves crude drugs and natural products derived from them
eg. Water content determination, Ash content, Acid Value
Miscellaneous/ Specific Method
a. Chemical
b. Physical
c. Biological
Based on materials used
Based on materials used
- Use of chemical reagents
Chemical
Based on materials used
- instruments and special apparatus
Physical
Based on materials used
- use of microorganisms, animals
Biological
