CURRENT GOOD MANUFACTURING PRACTICES AND FBRC • WUP • CAMP •

CURRENT GOOD COMPOUNDING PRACTICES PHARMACEUTICS 1

 1. List common terms used in the Current Good
Manufacturing Practice (cGMP) for finished pharmaceuticals
2. Describe the organization and personnel required by
cGMP

LEARNING 3. Describe the intent and importance of written procedures

within the various components of cGMP
OBJECTIVES: 4. Describe the various types of tamper-evident packaging,
and provide a product example of each type.
5. Differentiate between pharmaceutical manufacturing and
extemporaneous compounding
CURRENT GOOD MANUFACTURING PRACTICES
❑“Manufacturing” means the production, preparation, propagation,
conversion, or processing of a Drug or Device, either directly or indirectly, by
extraction from substances of natural origin or independently by means of
chemical or biological synthesis.
❑Manufacturing includes the packaging or repackaging of a Drug or Device
or the labeling or relabeling of the container of a Drug or Device for resale
by pharmacies, Practitioners, or other Persons.
STANDARDS FOR CGMP
❑ Current Good Manufacturing Practice (cGMP or GMP) regulations are established
by the Food and Drug Administration (FDA) to ensure that minimum standards are met
for drug product quality in the United States
❑ To ensure compliance, the FDA inspects the facilities and production records of all
firms covered by these regulations.
❑ The Code of Federal Regulations (CFR) contains
 (a)requirements for the “Current Good Manufacturing Practice for Finished Pharmaceuticals” and
 (b) additional cGMP requirements for biologic products,
 (c) medicated articles, and
 (d) medical devices.
 Active ingredient or active Certification:
pharmaceutical ingredient (API):
• Documented testimony by
• Any component that is intended to qualified authorities that a system
furnish pharmacologic activity or qualification, calibration, validation,
other direct effect in the diagnosis, or revalidation has been performed
cure, mitigation, treatment, or appropriately and that the results
prevention of disease or to affect are acceptable
the structure or function of the body
of man or other animals Compliance:
Batch: • Determination through inspection

COMMON • A specific quantity of a drug of

of the extent to which a
manufacturer is acting in
uniform specified quality produced accordance with prescribed

TERMS USED:
according to a single manufacturing regulations, standards, and
order during the same cycle of practices
manufacture
Component:
Batchwise control:
• Any ingredient used in the
• The use of validated in-process manufacture of a drug product,
sampling and testing methods in including those that may not be
such a way that results prove that present in the finished product
the process has done what it
purports to do for the specific batch Drug product:
concerned
• A finished form that contains an
active drug and inactive ingredients
 Inactive ingredient: Quality assurance:
• Any component other than the • Provision to all concerned the
active ingredients in a drug product evidence needed to establish
confidence that the activities relating
Lot: to quality are being performed
adequately
• A batch or any portion of a batch
having uniform specified quality and Quality audit:
a distinctive identifying lot number
• A documented activity performed
Lot number, control number, or in accordance with established
batch number: procedures on a planned and

COMMON • Any distinctive combination of

letters, numbers, or symbols from
which the complete history of the
periodic basis to verify compliance
with the procedures to ensure
quality

TERMS USED: manufacture, processing, packaging, Quality control:

holding, and distribution of a batch
or lot of a drug product may be • The regulatory process through
determined which industry measures actual
quality performance, compares it
Master record: with standards, and acts on the
difference
• Record containing the formulation,
specifications, manufacturing Quality control unit:
procedures, quality assurance
requirements, and labeling of a • An organizational element
finished product designated by a firm to be
responsible for the duties relating to
quality control
 Quarantine: volume
• An area that is marked, Verified:
designated, or set aside for the
holding of incoming components • Signed by a second individual
prior to acceptance testing and or recorded by automated
qualification for use equipment

Representative sample: Validation:

• A sample that accurately • Documented evidence that a

COMMON portrays the whole

Reprocessing:
system does what it purports to
do

TERMS USED: • The activity whereby the

Process validation:
• Documented evidence that a
finished product or any of its
components is recycled through process does what it purports to
all or part of the manufacturing do
process Validation protocol:
Strength: • A prospective experimental
• The concentration of the drug plan to produce documented
substance per unit dose or evidence that the system has
been validated
CURRENT GOOD MANUFACTURING PRACTICES
ORGANIZATION AND PERSONNEL
• The organization and personnel section of the regulations deals with the
responsibilities of the quality control unit, employees, and consultants
BUILDINGS AND FACILITIES
• Each building’s structure, space, design, and placement of equipment must be such
to enable thorough cleaning, inspection, and safe and effective use for the
designated operations.
EQUIPMENT
• Each piece of equipment must be of appropriate design and size and suitably
located to facilitate operations for its intended use, cleaning, and maintenance.
CURRENT GOOD MANUFACTURING PRACTICES
CONTROL OF COMPONENTS, CONTAINERS, AND CLOSURES
• Written procedures describing the receipt, identification, storage, handling, sampling, testing, and
approval or rejection of all drug product components, product containers, and closures must be
maintained and followed.
PRODUCTION AND PROCESS CONTROLS
• Written procedures are required for production and process controls to ensure that the drug
products have the correct identity, strength, quality, and purity
PACKAGING AND LABELING CONTROL
• Written procedures are required for the receipt, identification, storage, handling, sampling, and
testing of drug product and issuance of labeling and packaging materials.
EXPIRATION DATING
• To assure that a drug product meets applicable standards of identity, strength, quality, and purity
at the time of use, it must bear an expiration date determined by appropriate stability testing
CURRENT GOOD
MANUFACTURING
PRACTICES
TAMPER-EVIDENT
PACKAGING
ADDITIONAL CGMP REGULATORY REQUIREMENTS
ACTIVE PHARMACEUTICAL INGREDIENTS AND PHARMACEUTICAL EXCIPIENTS
• The application of the regulations is focused on all of the defining elements of
chemical purity and quality, including the following:
• Specifications and analytical methods for all reactive and nonreactive components used in synthesis
• Critical chemical reaction steps
• Handling of chemical intermediates
• Effect of scale-up of chemical batches on the yield
• Quality of the water systems
• Solvent handling and recovery systems
• Analytical methods to detect impurities or chemical residues and the limits set
• Stability studies of the bulk pharmaceutical chemical
 “Compounding” means the preparation of
Components into a Drug product

CURRENT GOOD (a) as the result of a Practitioner’s Prescription

Drug Order based on the
COMPOUNDING Practitioner/patient/Pharmacist relationship in the
course of professional practice, or
PRACTICES (b) for the purpose of, or as an incident to,
research, teaching, or chemical analysis and not
for sale or Dispensing.
PACKAGING, LABELING, AND STORAGE
OF PHARMACEUTICALS CONTAINERS
QUALITIES TESTED IN DIFFERENT TYPES OF CONTAINER :
 Physicochemical properties
 Light transmission for glass or plastic
 Drug compatibility
 Leaching and/or migration
 Vapor transmission for plastics
 Moisture barrier
 Toxicity for plastics
 Valve, actuator, metered dose, particle size, spray characteristics, and leaks for
aerosols
 Sterility and permeation for parenteral containers
 Drug stability for all packaging
 PACKAGING,
LABELING, AND
STORAGE OF
PHARMACEUTICALS
CONTAINERS
GLASS
PACKAGING, LABELING, AND STORAGE OF
PHARMACEUTICALS CONTAINERS
PLASTIC
Advantages: light weight, flexible, different shape
Disadvantage: permeation

TYPES:
Thermoplastic = can be squeezed (soft if heated, hard if cooled)
Thermoset = permanently hard and rigid when heated

Examples: POLYETHYLENE, POLYPROPYLENE, POLYETHYLENE TEREPHTHALATE

PROBLEMS ENCOUNTERED IN THE USE OF PLASTICS
IN PACKAGING
(a) Permeability of the containers to atmospheric oxygen and to moisture vapor,
(b) leaching of the constituents of the container to the internal contents,
(c) absorption of drugs from the contents to the container,
(d) Transmission of light through the container, and
(e) Alteration of the container upon storage
LABELING
❑All drug products distributed in the United States must meet the labeling
requirements in the Code of Federal Regulations
❑According to federal regulations, manufacturers’ drug product labeling
includes not only the labels on the immediate container and packaging but
also inserts; company literature; advertising and promotional material,
including brochures, booklets, mailing pieces, file cards, bulletins, price lists,
catalogs, sound recordings, film strips, motion picture films, slides, exhibits,
displays, literature reprints, and computer-accessed information; and other
materials related to the product
STORAGE
❑ To ensure the stability of a pharmaceutical preparation for the period of its
intended shelf life
STORAGE CONDITION TEMPERATURE
Cold temperature not exceeding 8°C (46°F)
Cool temperature between 8°C and 15°C (46°F and 59°F)
Room temperature usual working environment of 20°C to 25°C (68°F to 77°F)
Warm temperature between 30°C and 40°C (86°F and 104°F)
Excessive heat above 40°C (104°F)