QC2 QUALITY MANAGEMENT SYSTEM

being within prescribed limits

Conformance

functionality of the product

Fitness for use

function in the specified environment for a prescribed length of time

Reliability

with high degree of acceptable units produced

Repeatability

requires the product to be safe, pure and effective

Customer satisfaction

The aspect of management functions that determines and implements the "quality policy".

QUALITY MANAGEMENT

Infrastructure that covers the organizational structure, procedures & processes, and resources

QUALITY SYSTEM

Systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality

QUALITY ASSURANCE

Part of QA, which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization

GMP

Tool which gives assurance that a product conforms to standards and specifications through a system of inspection, analysis and action

QUALITY CONTROL

What section: Sample and examine all raw materials received

MATERIALS INSPECTION SECTION

What section: Maintain periodic examination on the quality of inventories

MATERIALS INSPECTION SECTION

What section: Perform audit

MATERIALS INSPECTION SECTION

What section: activities: physical and chemical analyses

ANALYTICAL LABORATORY

What section: activities: pharmacological, toxicological and microbiological analyses

BIOLOGICAL TESTING LABORATORY

What section: noise should be precluded from areas

BIOLOGICAL TESTING LABORATORY

What section: culture media; sterile conditions

BIOLOGICAL TESTING LABORATORY

What section: environmental monitoring for microbial and particulate matter

BIOLOGICAL TESTING LABORATORY

What section: personnel familiar with manufacturing, research, product development and statistics

SPECIFICATIONS & ANALYTICAL DEVELOPMENT

What section: departments for product improvements

SPECIFICATIONS & ANALYTICAL DEVELOPMENT

What section: develop new assay method for in-house use

SPECIFICATIONS & ANALYTICAL DEVELOPMENT

What section: main function: documentation

QUALITY CONTROL OFFICE

What section: investigate product complaints, evaluate returned products and reprocessing procedures

QUALITY CONTROL OFFICE

basic quality function of deciding whether the product conforms to specifications

acceptance

process of measuring, examining, testing, or otherwise comparing the unit of product with the requirements; the primary step of acceptance

inspection

the primary step of acceptance

inspection

applied to incoming materials, to partially finished product at various intermediate stages of manufacturing process (in-process inspection), and to the final product

Acceptance inspection

Types of Inspection: inspection by measuring the magnitude of a characteristic of an item

inspection by variables

Types of Inspection: inspection whereby either the unit of product is classified simply as conforming or nonconforming, or the number of nonconformities in the unit of products is counted, with respect to a given requirement or set of requirements

inspection by attributes

Inspection Methods : 100% INSPECTION

can sometimes degenerate into

superficial 100% inspection

not viable if the inspection method necessitates destructive testing

Inspection Methods : 100% INSPECTION

considers laws of probability

SAMPLING INSPECTION

risk of errors: producer's risk (a) is the probability of rejecting a good batch, whereas consumer's risks (B) is the probability of accepting a bad

batch

SAMPLING INSPECTION

sample chosen in such a manner that one object has a good chance of being selected as another

random sample

a departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement

non conformity

indicates the number of units of product from each lot or batch which are to be inspected and the criteria for determining the acceptability of the lot or batch

sampling plan

the quality level that is the worst tolerable process average, like higher than that = reject

acceptance quality limit AQL

Inspection Levels: may be specified when less discrimination is needed

Level I Reduced

Inspection Levels: will be used unless otherwise specified

Level II Normal

Inspection Levels: may be specified for greater discrimination

Level Ill Tightened

Sample Prep: Crude drugs in bulk: number of packages to be opened for sample withdrawal

Gross sample

Sample Prep: Crude drugs in bulk: top, middle, and bottom of container pooled together

Original samples

Sample Prep: Crude drugs in bulk: repeated quartering until the desired quantity is achieved

Average sample

Sample Prep: Crude drugs in bulk: average sample divided into 4

Final samples

Sample Prep: Crude drugs in bulk: Final sample steps:

1. degree of fragmentation (sieve test)

2. identity and level of impurities;

3. moisture and ash content;

4. level of active ingredients, where possible

Crude drugs in retail packages: (1-5 boxes) 10 consumer packages pooled together

Pooled sample (small batch)

Crude drugs in retail packages: - 2 consumer packages/box pooled together

Pooled sample (large batch)

Purified raw material/Starting materials: sampling may be done if a validated procedure has been established, except if starting materials are supplied by intermediaries or for use in parenteral products or square root system

Gross sample:

Purified raw material/Starting materials:

- amount of sample for one complete analysis

- dependent on the number of tests required in the drug monograph

- quantitative tests are performed twice

Test sample

Purified raw material/Starting materials: equal to three times the amount of sample for one complete analysis

Laboratory sample

Purified raw material/Starting materials: sample of a batch of starting material, intermediates, packaging material or finished product which is stored for analysis during the shelf-life; two times the amount for one complete analysis

Reference sample

In-process items: withdrawn on a time basis or as portions of batch

Gross sample

In-process items: based on GMP, in-house or pharmacopeial requirement

Laboratory sample

Finished products: based on the requirements of the analytical procedure

Test sample

Finished products: sample of a fully packaged unit from a batch of finished product which is stored for identification purposes, reference samples (in case of finished products) and retention samples may be regarded as interchangeable

Retention sample

Finished products: at least one retention sample should be taken from

each individual packaging operation

Finished products: parallel imported/parallel distributed products

:when secondary packaging is not opened

only the packaging material used needs to be retained

Finished products: parallel imported/parallel distributed products: when secondary packaging is opened

one retention sample per packaging operation

Packaging materials: Gross sample:

n plan

Packaging materials: Laboratory sample:

based on ANSI/AZQ Z1.4-2008 standard

Sampling Tools: for sampling small containers of solid materials

Scoops

Sampling Tools: for sampling containers of liquid and topical products

dip tubes

Sampling Tools: for sampling large tanks and storage vessels of liquid materials

weighted containers

Sampling Tools: for sampling deep containers of solids

thieves

Sampling Tools: for sampling bags of grains

spears

a unit that contains one or more defects (undesirable characteristics)

DEFECTIVE PRODUCT

DEFECTIVE PRODUCT Measurability: measurable

Variable

DEFECTIVE PRODUCT Measurability: non-measurable; descriptive

Attribute

DEFECTIVE PRODUCT: Seriousness/Gravity: renders product hazardous to health and useless

Critical

DEFECTIVE PRODUCT: Seriousness/Gravity: affects product functionality

major

DEFECTIVE PRODUCT: Seriousness/Gravity: alters overall product acceptability

minor

DEFECTIVE PRODUCT: Nature: nature, seen

Ocular

DEFECTIVE PRODUCT: Nature: not seen

Internal

DEFECTIVE PRODUCT: Nature: Defect in function

Performance

Controls - involves 5 variables

materials, manufacturing, packaging, distribution and environmental)

Material Control - applied to raw materials and packaging materials

1 inspectors

2 sampling and inspection

3 raw material analysis based on monograph

4 action: accept or reject

5 reassay

Warehouse personnel: receiving number per __

batch

Warehouse personnel: preparation of RTR meaning

receiving tally report

Warehouse personnel: quarantine sticker is pasted (color?)

yellow

Does visual examination, sampling

QC inspector

Approved Materials Area / Dispensing Area (color?) sticker

green

Tested on reassay dates: highly unstable

monthly or prior to use

Tested on reassay dates: vitamins and flavors

6 months

Tested on reassay dates: active ingredients and dyes

1 year

Tested on reassay dates: active ingredients & excipients

2 years

Kinds of Packaging Materials: Glass and glass containers: Type 1

highly-resistant, borosilicate

Kinds of Packaging Materials: Glass and glass containers: Type II

treated soda-lime

Kinds of Packaging Materials: Glass and glass containers: Type III

soda-lime

Kinds of Packaging Materials: Glass and glass containers: Type NP

general purpose soda-lime

Kinds of Packaging Materials: Metal and metal containers

tin plate or aluminum

Classes of Containers: protects contents from extraneous solids and from loss of contents

Well-closed

Classes of Containers: protects contents from contamination by extraneous liquid, solid or vapour, and from loss for hygroscopic substances

Tight

Classes of Containers: impervious to air or any other gas

hermetic

Classes of Containers: protects from light transmission at wavelength between 290 and 450 mm Uv VIS

Light-resistant

Classes of Containers: poses difficulty in opening for 5-year old child

Child-resistant

Light transmission test

uv vis spectrometer

Physico-Chemical Tests

chemical resistance test

determines the resistance of new glass containers to water attack

Physico-Chemical Tests

degree of attack is measured in terms of amount of alkali released from the glass

Physico-Chemical Tests

direct acidimetry two methods:

(1) Powdered Glass

(2) Water Attack at 121°