GOOD COMPOUNDING

PRACTICE

RANOA, ROMASANTA, TAGOLINO, VERGARA,

SPECIFIC LEARNING OBJECTIVES

At the end of this presentation, our classmates are

expected to:
• Distinguish Compounding from Manufacturing
• Know the importance of the General Principles, Quality
Assurance System, Personnel, Premises and
Equipment, Documentation, Compounding Process,
Quality Control, Complaints and Recall, and Self
Inspection.
 GOOD COMPOUNDING
PRACTICE
•Compounding is an integral part of pharmacy practice and is essential
to the provision of health care.
-defined as the preparation, mixing, assembling, altering, packaging
and labeling of a drug, drug delivery device in accordance with licensed
practitioner’s prescription, medication order, or initiative based on
practitioner-patient-pharmacist- compounder relationship in the course
of professional practice. ( USP 795 )
 Compounding includes:
•Preparation of drug dosage forms for both hu an and animal patients
•Preparation of drugs or devices in anticipation of prescription of drug
orders.
•Manipulation of commercial products that may require the addition of
one or more ingredients.
 Compounding includes:
•Preparation of drugs or devices for the purpose of, or as an incident to,
research ( clinical or academic), teaching , or chemical analysis..
•Preparation of drugs and devices for prescriber’s office use where
permitted by federal and state law.
 Distinguishing Compounding from Manufacturing

Compounding: Act of preparing, mixing, assembling, packaging, and labeling a drug or

device.

1. Practitioner – Patient – Pharmacist

2. Chemical analysis

3. Preparation of drugs and devices in anticipation of prescription drug orders

Manufacturing: The production, preparation, propagation, conversion, and processing of

a drug or device, either indirectly or directly, through the extraction of substance from
natural origin or through the means of chemical or biological synthesis.
Guideline for distinguishing compounding
and manufacturing are as follows:

1. Pharmacist may compound, in reasonable quantities, drug preparations

and a pharmacist – patient – prescriber must exist.

2. Pharmacist may compound nonprescription medications in

commercially available dosage forms or alternative dosage forms.

3. Pharmacist should not offer compounded medications to other

pharmacist for resale; however. A practitioner may obtain compounded
medication but should be labeled “For Office Use Only”.

4. Compounding pharmacies and pharmacists may advertise or otherwise

promote the fact that they provide prescription compounding services.
GLOSSARY
 ACTIVE INGREDIENT

Any substance to which the effect of a finished medicinal

product acts as such

BATCH

Defined quantity of starting materials

 BATCH NUMBER
Distinctive combination of numbers which identifies a
batch

BEYOND-USE DATE
Date which a compound should not be
used
 CLEAN AREA
Area with defined environmental control of particulate
and microbial contamination

CLOSED PROCEDURE
A sterile pharmaceutical product is transferred
to a pre-sterelized sealed container, without
exposing to external environment
 CRITICAL ZONE
Work area where containers are opened and product is
exposed.

CROSS
CONTAMINATION
Contamination of a product/material to another
product/material.
 DEVIATION REPORT
Deviation from standard procedures and documentation
that occurs

DISPENSED MEDICINE
Section 19 of Poisons Act 1952: medicine supplied by a
registered medical practitioner
 IN-USE EXPIRY DATE
End of application period of a medical product

PACKAGING
Bulk products should undergo filling and labelling
 PACKAGING
MATERIAL
Referred to as primary or secondary according to
whether or not they are in direct contact with the product

PRODUCTION
Involves all processes and operations in preparation of
product
 PHARMACEUTICAL ISOLATOR

Containment device which utilizes barrier technology to

provide an enclosed, controlled workspace

RESPONSIBLE
PERSON
Ultimately responsible for all aspects of preparation
 RISK ASSESSMENT
a. What might go wrong?
b. What will go wrong?
c. What are the consequences?

SELF INSPECTION
Assessment of same organization to monitor validity of
quality assurance system
 STARTING MATERIAL
Substance used for the preparation of a compounded
preparation excluding packaging material

VALIDATION
Risk-based, systemic, GMP compliant and documented
evidence of the process and its result
GENERAL PRINCIPLES
 GENERAL PRINCIPLES

COMPOUNDED PREPARATIONS
provided only if safe and
appropriate

prepared in reference to
international
pharmacopoeias or
references recognized by the
Drug Control Authority
 GENERAL PRINCIPLES

COMPOUNDED PREPARATIONS
provided only if safe and
appropriate

prepared in reference to
international
pharmacopoeias or
references recognized by the
Drug Control Authority
 GENERAL PRINCIPLES

A COMPOUNDED PREP. SHOULD BE PREPARED

ONLY IN CIRCUMSTANCES WHEN:

a) A Registered Product is unavailable in the

market
b) RP w/ similar therapeutic effect is
unavailable in the market
c) RP is unsuitable (e.g. allergy to the excipient)
 GENERAL PRINCIPLES

A COMPOUNDED PREP. SHOULD BE PREPARED

ONLY IN CIRCUMSTANCES WHEN:

d) When undertaking research sanctioned by a

recognized human research ethics committee
e) A treatment requires tailored dosage
strengths/forms for patients with unique needs
(ex. an infant)
 GENERAL PRINCIPLES

WHAT IF A COMPOUNDED PREP. HAS:

 NO PRECEDENTS IN REPUTABLE REFERENCES
 LACKS OF PULISHED SAFETY, EFFICACY, PHARMACOKINETIC AND
CLINICAL DATA
 GENERAL PRINCIPLES

THE COMPOUNDED PREPARATION MUST BE

JUSTIFIED WITH:
a) A basis for the assigned BUD of the intended formulation; and
b) A basis for the safety of the intended user
 GENERAL PRINCIPLES

COMPOUNDED PREP. MAY INCLUDE BUT NOT

LIMITED TO:

a) Prep. containing
hormones
 GENERAL PRINCIPLES

COMPOUNDED PREP. MAY INCLUDE BUT NOT

LIMITED TO:
b.) Prep. compounded for topical use that contain drugs for which
oral use is well established
 GENERAL PRINCIPLES

COMPOUNDED PREP. MAY INCLUDE BUT NOT

LIMITED TO:
c.) Modified release
medicines in the absence
of good pharmacokinetic
and clinical data on the
precise formulation
intended for use
 GENERAL PRINCIPLES

COMPOUNDED PREP. MAY INCLUDE BUT NOT

LIMITED TO:
d.) Preparation containing Dangerous Drugs, Psychotropic, and
Precursor substances as permitted by relevant law and subject to
approval
 GENERAL PRINCIPLES

COMPOUNDED PREP. MUST NOT:

a) Contain substances which

are prohibited by the Drug
Control Authority (DCA) or
substances stated in Group
A of the Poisons List
(Poisons Act 1952)
ex. alclofenac, amidopyrine
 GENERAL PRINCIPLES

COMPOUNDED PREP. MUST NOT:

b.) Consist of parenteral

medicine containing
combinations of ingredients
where there is no
compatibility data
 GENERAL PRINCIPLES

COMPOUNDED PREP. MUST NOT:

c.) Be intended for

recreational purpose where
the benefit of having the
substances compounded is
not proven (e.g.: nicotine)
 GENERAL PRINCIPLES

Compounded preparations in anticipation of prescription drug

orders:

 shall be allowable on the basis of routine,

 regularly observed prescribing patterns and
 must not exceed BUD as stipulated in international
pharmacopoeia such as United States Pharmacopeia
(USP) Pharmaceutical Compounding – Nonsterile
Preparations Chapter <795> and Pharmaceutical
Compounding – Sterile preparations Chapter <797>.
 GENERAL PRINCIPLES

COMPOUNDING MAY INCLUDE THE FF.:

a.) Preparation of drug dosage
forms for human patients

b.) Modification of registered

products that may require the
addition of one or
more substances
 GENERAL PRINCIPLES

COMPOUNDING MAY INCLUDE THE FF.:

c.) Preparation of drugs or devices for
the purposes of research (clinical or
academic), teaching, or chemical
analysis

INVESTIGATIONAL CONTACT LENS

ECHINACEA IN PREVENTION TRIALS
IN TREATMENT TRIALS
 GENERAL PRINCIPLES

COMPOUNDING MAY INCLUDE THE FF.:

d) Sterile preparations and preparations

which require special competencies,
equipment's, processes or facilities and
containing ingredients that pose
occupational health and safety hazard
(such as cytotoxic or hormones).
(Please refer to Annex 1: Guidelines on the Standards Required for the Sterile Compounded Preparations)
Quality Assurance
System
PRINCIPLE
Compounded preparations
should be of high quality and
safety

Comprehensive designed and

correct implementation of quality
assurance system
THE PURPOSE OF THE QUALITY
ASSURANCE SYSTEM IS TO . . .
ensure that the compounded
preparations are of the quality
required for intended purpose
and consistently complies with
defined requirements
SPECIFALLY ON WHETHER . .
 Compounded preparations are formulated
and compounded according to latest available
information.

Operations are clearly specified and

implemented according to guidelines

Only supplied if they have been correctly

processed, check and stored in accordance
and released by responsible professionals
Adequate measures are in place to
ensure that compounded
preparations are released, stored and
handled in such a way that the
required quality can be assured
throughout their BUD.

Documentation systems are in place

and maintained
 Personnel
Principles: There should be an adequate number of
personnel having knowledge, skill and capabilities
relevant to their assigned function.
Responsible person:
• A pharmacist or a person working under the
immediate personnel supervision of a pharmacist.
• A person acting in the course if his duties who is
employed in hospital or dispensary maintained by the
Federal or any state government.
• A fully registered medical practitioner working under
an personal supervision of such a practitioner if the
drug in question if for the use of such patient.
Qualification:
• Possess suitable qualifications required for their jobs
• Have adequate experience and are technically
competent
• Regularly trained during their employment for the
purpose of keeping up to date with any advancement
or changes.
Responsibilities:
• Ensure all compounding preparations of
acceptable strength and quality to ensure the
authenticity of the order.
• Ensure all compounding processes are
conducted appropriately.
• Ensure the compounded preparation is
supplied with appropriate packaging and
labeling.
• Ensure all compounding processes have
been documented accordingly.
• Ensure all compliance to relevant acts and
regulations.
Personnel Hygiene:
• Prevent direct contact with any compounding
components and substances during
compounding process.
• Should wear appropriate clean clothing
during operations.
• Unhygienic practice is forbidden within the
compounding areas.
PREMISES AND EQUIPMENT
 PREMISES AND EQUIPMENT

PRINCIPLES
• Defined and reserved areas for • Adequate Compounding
the compounding activity equipment and should be easily
available for its intended use
 PREMISES AND EQUIPMENT

FACILITIES

must ensure all

compounding activities
take place in premise
that is adequately
designed, equipped and
maintained
RESPOSINBLE PERSON
 PREMISES AND EQUIPMENT

FACILITIES
 isolated from potential
interruptions, chemical
contaminants and source
of dust and particulate
matter
 away from routine
dispensing and
counselling functions COMPOUNDING AREA
 PREMISES AND EQUIPMENT

FACILITIES

 adequate place for

equipments and materials
 shall be designed and
arranged
prevent mix-ups and cross-
contamination
COMPOUNDING FACILITY
 PREMISES AND EQUIPMENT

FACILITIES

Lighting, temperature,
humidity and
ventilation should be
appropriate

STERILE COMPOUNDING AREA

 PREMISES AND EQUIPMENT

FACILITIES

designed and equipped to

afford maximum protection
against the entry of pests
or other animals

COMPOUNDING FACILITY
 PREMISES AND EQUIPMENT

FACILITIES

 smooth, impervious, and

free of cracks and crevices
(preferably seamless) and
non-shedding

WORK SURFACE
 PREMISES AND EQUIPMENT

FACILITIES

Adequate facilities for

washing hand and
equipment should be easily
accessible to the
compounding area
COMPOUNDING FACILITY
 PREMISES AND EQUIPMENT

FACILITIES

Hormones, cytotoxic and hazardous drugs shall be

stored, prepared, and handled by Responsible Person
under conditions that protect other personnel
 PREMISES AND EQUIPMENT

COMPOUNDING EQUIPMENT

 depends on
the particular
dosage form
requested
 PREMISES AND EQUIPMENT

COMPOUNDING EQUIPMENT

 shall have appropriate

design and has the
capacity according to
dosage forms and the
quantities compounded
 PREMISES AND EQUIPMENT

COMPOUNDING EQUIPMENT

made of suitable
materials
the surface of the
contact component
should be neither
reactive nor additive
 PREMISES AND EQUIPMENT

COMPOUNDING EQUIPMENT

 Automated and
other types of
equipment shall be
routinely inspected,
calibrated
 PREMISES AND EQUIPMENT

COMPOUNDING EQUIPMENT
Extra care should be practiced
when cleaning equipment used
in compounding preparation
require special precautions (e.g.
hormones, antibiotics, cytotoxic
and other hazardous materials).
When possible, dedication of
equipment or single use
equipment should be practiced
to reduce chances of bio burden
and crosscontamination.
 DOCUMENTATION
PRINCIPLES

Good documentation constitutes an essential part of the

quality assurance system. Clearly written documentation
prevents error from spoken communication and permits
tracing of batch history of complementary preparation.
Suitable control should be in place to ensure accuracy.
 Compounding documents should include:

•Master Formula
•Compounding records
•Standard Operating Procedures and its relevant records
•Records such as Certificates of Analysis and Material
Safety Data

All records and reports should be readily available for

authorized inspection during retention period.
 MASTER FORMULA
This records shall include:
a. Official or assigned name, strength, and dosage of
preparations
b. Calculations needed to determine and verify
quantities of components and doses of AI.
c. Description of ingredients and their quantities
d. Compatibility and stability information
 MASTER FORMULA
e. Equipment needed o prepare
f. Mixing instructions
g. Sample of labeling information of the compounded
preparation
h. Container used in compounding
i. Packaging and storage requirement
 COMPOUNDING
RECORDS
Compounding records should include:
•Processing
•Packaging
•Quality control documents
•Name of person who does the compounding
•Date of compounding
•Reference to prescription order
 COMPOUNDING
RECORDS
•Quantity of stock
•Balance stock
•Stock card
•And any other relevant documentation as required by law
Standard Operating Procedure
All significant procedures performed in the compounding
area should be addressed by written standard operating
procedures.
 Compounding process

Principles: Should be capable of producing compounded preparation which

conform to their specification.

General: The quantity of compounded medicine to be supplied should be in a unit

of use for the individual. Responsible person should evaluate the dose, safety
and intended use in terms of chemical and physical properties of the
components.

Ingredients: Source of Active Pharmaceutical Ingredients may be derived from

registered products. Ingredients should be used accordingly its indication and
potential effect on the efficacy, strength, purity, stability, compatibility, and quality.
Packaging, storage, and labeling:

Selection of container depends on the chemical and physical properties of the

compounded preparations. Packaging material should not interact with the
chemical and physical properties of the preparations to maintain the potency
during storage.
Labeling of compounded preparations:
• Generic names of main active ingredients
• Strength and quantity
• Batch number: traceable to the compounded preparation
• Beyond – use date
• Storage requirement
Q U A L I T Y C O N T RO L

P R I N C I P L E

Every compounding process

should have a quality
control system to ensure
that compounding
preparations are prepared in
accordance with the
established specifications.
Q U A L I T Y C O N T RO L

G E N E R A L

Wr i t t e n p r o c e d u r e s s u c h a s
listing of ingredients, order
of mixing and detailed
description of compounding
process should be available
including the equipment as
well as the container
closure system.
Q U A L I T Y C O N T RO L
G E N E R A L

All compounding records

and final checks should be
reviewed for accuracy and
conduct in the process.
Operation at each step of
weighing and measuring of
compounding process
should be counter checked
by Responsible Person.
Q U A L I T Y C O N T RO L
 B E Y O N D - U S E D AT E ( B U D )

Sign of instability should be

observed at all stages of
compounding process.
 COMPLAINTS
Error, defects, complaints and other signs indicating
quality problem should bee investigated.

RECALLS – when deficiencies are potentially harmful to

health, a recall should be initiated immediately. A written
procedure for a recall should be in place. It should be
guaranteed that they cannot supply error. The progress of
recall should be recorded.
Self-Inspection
PRINCIPLE
Monitored implementation and
compliance with the principles of
GCP and applied necessary
corrective and preventive measures.

Self-inspection should be
conducted.
QUALITY ASSURANCE SYSTEM FOR
ALL AREAS SHOULD BE EXAMINED
SUCH AS . . .

PERSONNEL PREMISES EQUIPMENT

DOCUMENTATION PRODUCTION QUALITY CONTROL

DISTRIBUTION OF COMPOUNDED PREPARATION

ARRANGEMENTS FOR DEALING WITH COMPLAINTS

AND OUTSOURCED ACTIVITES
HOW SELF-INSPECTION
PROGRAM BE IMPLEMENTED?
provide annual self-inspection
plan considering the complexity
and the type of the operations.

Records and Evidences

 CONCLUSION
Good Compounding Practice should be monitored
on a regular basis to be able to identify whether it
conforms to the said guidelines and also minimize
the possibility of having quality degradation and
contamination of product. This practice should be
implemented to every hospital setting to be able
to provide the necessary medical assistance to
the patients.
WHAT DOES GMP MEAN?

Good Manufacturing Practice (GMP) is a system for ensuring

that products are consistently produced and controlled
according to quality standards. It is designed to minimize the
risks involved in any pharmaceutical production that cannot be
eliminated through testing the final product.
WHY IS GMP IMPORTANT?

Good Manufacturing Practices (GMPs) are systems created

and mandated by the government to regulate production,
verification and validation of drugs, food and/or medical
devices, ensuring that finished products are effective and safe
for market distribution.
IS GMP NECESSARY IF THERE IS A QUALITY
CONTROL LABORATORY?

Yes. Good quality must be built in during the manufacturing

process; it cannot be tested into the product
afterwards. GMP prevents errors that cannot be eliminated
through quality control of the finished product.
CAN MANUFACTURERS AFFORD TO
IMPLEMENT GMP AND WHY?

Yes. Implementation of GMP is an investment in good quality

medicines. This will improve the health of the individual
patient and the community, as well as benefiting the
pharmaceutical industry and health professionals.
DOCUMENTATION IS

a. A system of records
b. Only written on paper
c. Only electronic
d. A seal of approval
DOCUMENTATION IS

a. A system of records
b. Only written on paper
c. Only electronic
d. A seal of approval
GOOD LABORATORY PRACTICES IS ALSO
CALLED
a. GLP
b. Common sense
c. Safety
d. Unnecessary
GOOD LABORATORY PRACTICES IS ALSO
CALLED
a. GLP
b. Common sense
c. Safety
d. Unnecessary
DIRECTIVE DOCUMENTS ARE NOT

a. Protocols
b. Laboratory notebooks
c. SOPs
d. Labels
DIRECTIVE DOCUMENTS ARE NOT

a. Protocols
b. Laboratory notebooks
c. SOPs
d. Labels
DATA COLLECTION DOCUMENTS ARE

a. Protocols
b. Goals, standards, commitments
c. Instructions
d. Chain of custody forms
DATA COLLECTION DOCUMENTS ARE

a. Protocols
b. Goals, standards, commitments
c. Instructions
d. Chain of custody forms
COMMITMENT DOCUMENTS

a. Protocols
b. Goals, standards, commitments
c. Instructions
d. A record of data
COMMITMENT DOCUMENTS

a. Protocols
b. Goals, standards, commitments
c. Instructions
d. A record of data
SOP STANDS FOR

a. Standard Operating Procedure

b. Statement of the Problem
c. Statement of Position
d. Statement of Purpose
SOP STANDS FOR

a. Standard Operating Procedure

b. Statement of the Problem
c. Statement of Position
d. Statement of Purpose