©to respective owner NCII
Course Orientation,
House Rules and
Pre-laboratory
discussion
Pharmaceutics 2 (PMC2)
BSP 3B
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
Preliminary period
Course Orientation
Syllabus
Requirements
House Rules
Pharmaceutics 2 (PMC2)
Laboratory Rules
BSP 3B
AO 55 s.1988:
Requirements for Labelling
Materials of Pharmaceuticals
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
AO 109 s.1969
Prescription Drug
Label Symbol
Preliminary period
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
Course
Orientation
Preliminary period
Course Objective
At the end of the course the students should be able to:
1. Cognitive:
Practice and apply the principles of the GxP’s, with particular emphasis on
GDP, GMP, GPP in the production of pharmaceuticals, cosmetics and
veterinary products.
2. Psychomotor:
Dispense, manufacture, label and package a pharmaceutical, cosmetic, and
veterinary product, in adherence and compliance to GxP’s.
3. Affective:
Appreciate the pharmacist’s social professional responsibilities in helping
restore or maintain the health of men and animals and of the high moral
and ethical standards that are required of the pharmacy profession.
Preliminary period
Manufacture of Drugs, Cosmetics and
Veterinary Medicine
5 unit subject: 3 lecture, 2 laboratory
The course familiarizes the students with the concept of
cGMP involved in pharmaceutical manufacture. Acquisition
of the basic knowledge in the regulatory and technical
requirements of the Food and Drugs Administration in the
production of Drugs, Cosmetics and Veterinary products.
PRE-REQUISITE:
Pharm.5 – Biopharmaceutics and Pharmacokinetics
Preliminary period
Requirements:
During preparation day:
1. Complete PPI
2. Task tag
To be passed after each preparation day
30mins. before end of session
(10) 1. One (1) fully accomplished answer sheet per group
(45) 2. Preparation
*** 3. Index card
To be passed on the 2nd meeting before the final
examination (1st period of session):
1. An advertisement in a form of a commercial.
30 second commercial for 5 preparations (2min 30sec)
(any preparation)
(CD burned)
2. A portfolio of your preparations.
Preliminary period
Criteria for preparations:
Each preparation is equivalent to 50 points.
Part 1: Secondary packaging
Design
Readability
Adherence to AO 55 and AO 109
Capability to carry primary container
-3
-2
-5 *
-3 *
Part 2: Primary packaging
Design
Readability
Adherence to AO 55 and AO 109
Appropriateness of container
-3
-2
-5 *
-5 *
Part 3: Content
(depends on preparation)
- 15
Part 4: Package insert
Readability
Content
-2
-5
Preliminary period
Class Participation
Each laboratory session day:
Attendance: (grace period of 15 min. PST)
Present: 2 pts.
Late: 0.5 pt. (up to 30 min. only)
Absent: 0 pt.
*in final computation of grade,
an excess of 0.5 is not rounded off to 1
Preliminary period
Class Participation
Each laboratory session day:
Deduction guide:
No/improper use of head cap:
-2
No/improper use of face mask:
-2
* No gloves:
-2
No shoe cap:
-1
With jewellery/nail polish/facial hair - 1/ part/pc
No/improper use of lab gown:
- no experiment
No task tag
-1
*Sitting while course of experiment
-2
Cluttered worktable
-5
*not applicable to labeller
Deduction procedure:
1. Random inspection
2. Deduction to members = Deduction to inspector
3. Deduction to inspector = Deduction to inspector
4. Above guide is to be applied on the total score
Preliminary period
Class Participation
Each preparation day:
Deduction guide:
Late submission
- 5 per 10mins.
Deduction procedure:
1. Submission is 30 min. before end of session.
2. Deduction applies to the total grade on preparation
Preliminary period
Class Participation
Each preparation day:
Maximum total possible score:
Preparation:
50 pts.
Answer sheet: 10 pts.
Attendance:
2 pts.
62 pts.
Preliminary period
.
Reminders:
20% absences,
consecutive or non-consecutive:
automatic unofficially drop.
Preliminary period
Criteria for project
50 points
10 Originality
20 Adherence to current laws governing advertisement of
pharmaceutical products
20 Content
*late submission deduction guide applies
Preliminary period
Materials needed/group
Tissue / lint-free tissue
Mantle
Masking tape
Permanent marker
Dishwashing liquid/hand soap
Rags
Sando bag
Preliminary period
Preliminary period
©to respective owner NCII
Course Orientation,
House Rules and
Pre-laboratory
discussion
Pharmaceutics 2 (PMC2)
BSP 3B
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
Preliminary period
Course Orientation
Syllabus
Requirements
House Rules
Pharmaceutics 2 (PMC2)
Laboratory Rules
BSP 3B
AO 55 s.1988:
Requirements for Labelling
Materials of Pharmaceuticals
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
AO 109 s.1969
Prescription Drug
Label Symbol
Preliminary period
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
House Rules
Preliminary period
Complete PPI
Before Session:
1. Anteroom
2. Proper hand washing
During Session:
1. No sitting
2. Maintain cleanliness of workplace
Process: Inspector with all members:
a. Dispensing/Weighing
b. Compounding
c. Labelling
** inspector must make sure to supervise all task. Follow laboratory manual.
After session policy
1. CLAYGO
Pre-laboratory discussion:
1st meeting per week
Measurements and preparation for manufacturing order
1st meeting per week
Post-laboratory discussion:
Week before examination
*Expect 2 M.O. per preparation day.
Course
Orientation
Preliminary period
Preliminary period
©to
©torespective
respectiveowner
ownerNCII
NCII
Course Orientation,
House Rules and
Pre-laboratory
discussion
Pharmaceutics 2 (PMC2)
BSP 3B
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
Preliminary period
Course Orientation
Syllabus
Requirements
House Rules
Pharmaceutics 2 (PMC2)
Laboratory Rules
BSP 3B
AO 55 s.1988:
Requirements for Labelling
Materials of Pharmaceuticals
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
AO 109 s.1969
Prescription Drug
Label Symbol
Preliminary period
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
AO 55 s.1988:
Requirements for
Labelling Materials of
Pharmaceuticals
Preliminary period
Requirements for labelling
materials of pharmaceutical
products
Formulated by DOH with accordance to
RA 3720 with amendments from EO 175
and RA 6675
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Label on immediate container, and other printed
materials that are incorporated with the product
at the time of purchase.
E.g. Wrapper cartons, leaflet/package insert.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
refers to pharmaceutical products, which mean
any pharmaceutical or biological intended to be
used in the Dx, cure, mitigation and Tx or
prevention of dse
in human or affect the structure
or any fx of the
.
human body.
.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
proprietary or trade name assigned to the
product by the drug establishment
Preliminary period
Requirements for labelling materials of
pharmaceutical products
refers to the identification of drugs and
medicines by their scientifically and
internationally recognized active ingredients
determined by the FDA of the DOH
Preliminary period
Requirements for labelling materials of
pharmaceutical products
classification of the product based on the Tx
action as specified in the product registration
Preliminary period
Requirements for labelling materials of
pharmaceutical products
refers to the name(s) and amount(s) of
active medicinal ingredients per dosage unit
expressed in the METRIC system
Preliminary period
Requirements for labelling materials of
pharmaceutical products
the approved clinical use of the product based
on substantial and scientifically supported
evidence of the safety and efficacy of the drug
in the given dosage form
Preliminary period
Requirements for labelling materials of
pharmaceutical products
pharmaceutical form of the preparation based
on the official pharmacopoeia
Preliminary period
Requirements for labelling materials of
pharmaceutical products
the site and manner the product is to be
introduced in or applied on the body
Preliminary period
Requirements for labelling materials of
pharmaceutical products
statements regarding the occurrence of potential
hazards and side effects associated with use of
the product and the limitation of its use
Preliminary period
Requirements for labelling materials of
pharmaceutical products
statements regarding the occurrence of potential
hazards and side effects associated with use of
the product and the limitation of its use
Preliminary period
Requirements for labelling materials of
pharmaceutical products
instruction and special care required in the use
of the product to avoid undesired effects and to
ensure the safe and effective use of the drug
Preliminary period
Requirements for labelling materials of
pharmaceutical products
products other than biological products means
the date, in month and year, during which
processing of the bulk product, from which
goods are to be filled, is completed
Preliminary period
Requirements for labelling materials of
pharmaceutical products
refers to any distinctive combination of letters
and/or numbers, assigned to a particular batch
produced during a given cycle of manufacture.
It permits production history of the batch
including all stages of manufacture
and control, to be traced
and reviewed.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
distinctive combinations of letters and/or
numbers assigned to a particular lot,
defined as a portion of the batch
Preliminary period
Requirements for labelling materials of
pharmaceutical products
date after which the product is not expected to
retain its claimed safety, efficacy and quality or
potency or after which it is not permissible to
sell, distribute or use said product.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
total amount/quantity/number of dosage form in
a certain container of the product expressed in
metric system
Preliminary period
Requirements for labelling materials of
pharmaceutical products
refers to prevailing specified range temperature,
humidity and other environmental factors within
optimal stability of the product is ensured based
on laboratory data
Preliminary period
Requirements for labelling materials of
pharmaceutical products
part of the label that is most likely to be
displayed, presented, shown or examined under
customary condition of display for retail use
Preliminary period
Requirements for labelling materials of
pharmaceutical products
area or surface of the container/package where
the display panel is located
Preliminary period
Requirements for labelling materials of
pharmaceutical products
first pack containing the
individually wrapped products,
strip blister packs
Preliminary period
Requirements for labelling materials of
pharmaceutical products
1. Name of the product
(GN alone or with BN, as the case may be)
2. Dosage Form and strength
3. Pharmacologic Category
4. Rx symbol, in case of prescription drug
5. Name and complete address of manufacturer
6. Net Content
7. Formulation
8. Indication
9. Contraindication/s, Precaution/s, Warning/s
10. Mode of administration or Directions for use
11. Batch and Lot number
12. Exp. date and date of Mfg.
13. Registration number
14. Storage conditions
15. For Rx drugs:
FOODS, DRUGS, DEVICES AND COSMETIC ACT
PROHIBITS DISPENSING WITHOUT PRESCRIPTION
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Requirements for labelling materials of
pharmaceutical products
• Must be in English or Filipino
• It should be Clearly and Prominently Displayed
• Readable with normal vision without straining
• Color contrast, position and spacing of the
information must be taken into consideration in
complying with the reqmt’s
Preliminary period
PRINCIPAL
DISPLAY
PANEL
Contain the following:
1. Name of the product
(GN alone or with BN, as the case may be)
2. Dosage Form and strength
3. Pharmacologic Category
4. Rx symbol, in case of prescription drug
5. Name & complete address of
manufacturer
MUST…
Preliminary period
6. Net Content
Requirements for labelling materials of
pharmaceutical products
PRINCIPAL
DISPLAY
PANEL
MUST…
Preliminary period
Comprise 40% of the total surface of the
container, except in the case of the
rectangular container where the total
area of the principal display panel must
equal to the product of the height and
width of the entire side of the container.
For any other shaped container
presenting an obvious principal display
panel such as the top of a triangular or
circular container, the size of the area
shall consist of the entire top surface.
Requirements for labelling materials of
pharmaceutical products
MUST CONTAIN THE FOLLOWING
1. Formulation
2. Indication (s)
3. Mode of Administration(s)
and the Direction(s) for use
4. Batch and Lot number
5. Expiry/Expiration date of manufacture
6. Registration number
7. Storage Conditions
8. Rx notice for Rx drugs:
FOODS, DRUGS, AND DEVICES AND
COSMETIC ACT PROHIBITS DISPENSING
WITHOUT PRESCRIPTION
Preliminary period
IMMEDIATE
CONTAINER
OUTSIDE
OF THE
PRINCIPAL
DISPLAY
PANEL
Requirements for labelling materials of
pharmaceutical products
These informations shall appear
on the other labelling materials
such as inserts or leaflets or
wrapper cartons.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME
Brand Name of Some Drug
Specific requirements for the name of the product in
labelling drug products
IN ALL CASES, THE GENERIC NAME shall be the
prominently printed element on the label,
It is defined as the one with the highest point size among
various printed elements on the label.
It shall be enclosed exclusively by an outline box rendered
in the same color as the generic name
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME
Brand Name of Some Drug
Specific requirements for the name of the product in
labelling drug products
The background color inside the box,
against the GN is rendered,
should be the same color
as the background color outside the box,
against which the BN is rendered
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME salt form
Brand Name of Some Drug
Specific requirements for the name of the product in
labelling drug products
IN ALL CASES, the GN shall be printed in full,
NOT abbreviated and in accordance with the
International Non-proprietary Name (INN).
In cases the salt or specific chemical form of the drug
needs to be indicated, this must be included inside the but
in smaller font size
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME salt form
Brand Name of Some Drug
Specific requirements for the name of the product in
labelling drug products
GN and BN shall be of the same typeface, font and color
GN shall appear immediately above the brand name and
rendered in a point size bigger than the brand name
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME
salt form
Brand Name
Specific requirements for the name of the product in
labelling drug products
If the BN is presented with a special typeface exclusively
designed and used for it.
The GN shall be rendered in HELVETICA MEDIUM or
UNIVERSE MEDIUM be rendered while complying with
the pertinent provisions presented earlier.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Active1 Active2
Brand Name of Some Drug
Specific requirements for the name of the product in
labelling drug products
For products containing TWO (2) active ingredients:
The GN of both active ingredients indicated within the box
for generic name.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Active1 Active2
Brand Name of Some Drug
Specific requirements for the name of the product in
labelling drug products
For products containing THREE or MORE active ingredients:
An official name for the combination,
which shall serve as the equivalent generic name,
Shall be designated by a FDA committee of experts.
Starting date at which the official name can be used shall
be determined by FDA.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME salt form
Brand Name of Some Drug
TABLET
Requirements for labelling materials of
pharmaceutical products
Dosage form shall be specified as:
TABLETS, CAPSULES, SYRUPS, SUSPENSIONS,
OINTMENTS, including special delivery system such as
SUSTAINED-RELEASE, etc.
Preliminary period
GENERIC NAME salt form
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Shall conform to the category used in the PNDF.
Drugs that cannot be classified under the said categories
may be given a Tx category other than what appears in
annex “A” of AO55 s.1988
subject to the approval of FDA taking into consideration
current acceptable standards for Tx categories.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME salt form
Brand Name of Some Drug
Rx
TABLET
ANTIPYRETIC
It must be printed in contrasting color to the background on
which it appears.
Overprinting or superimposition of the Rx symbol is
allowed PROVIDED that such will not result in obliterating
or rendering less legible the other required label
requirements.
The Rx symbol should be printed in a type size no less
than 1/5 of the height of the principal display panel.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
GENERIC NAME salt form
Brand Name of Some Drug
Rx
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Complete name and address of manufacturer and also
trader, when applicable, must appear on the principal
display panel.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Net content shall indicate the total
amount/quantity/number of the dosage form in a given
container of the product expressed in metric system
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
Formulation:
Brand name of Some
Drug contains:
Generic Name……… 50mg
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Active ingredients must be stated in their generic names
(INN).
The amounts of the active ingredients shall be expressed
in the metric system/unit of potency.
Salt or chemical forms must be stated, when applicable.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
Formulation:
Brand name of Some
Drug contains:
Generic Name……… 50mg
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Multiple components must be enumerated in decreasing
pharmacologic activity.
The coloring agent and other excipients used in the
formulation that may cause hypersensitivity/ADR must be
indicated.
Alcohol content must be expressed in percent.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Formulation:
Brand name of Some
Drug contains:
Generic Name……… 50mg
Indication:
For patients with……
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
shall only be the approved clinical use of the product
Based on approved FDA registration
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Formulation:
Brand name of Some
Drug contains:
Generic Name……… 50mg
Indication:
For patients with……
Contraindicated to…
Warning:
Precaution:
Full information regarding contraindications to the use of
the product as well as precautions are to be observed in its
administration and use must be provided.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Formulation:
Brand name of Some
Drug contains:
Generic Name……… 50mg
Indication:
For patients with……
Contraindicated to…
Warning:
Precaution:
Warning statements as required and specified by FDA
must be provided.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Formulation:
Brand name of Some
Drug contains:
Generic Name……… 50mg
Indication:
For patients with……
Contraindicated to…
Warning:
Precaution:
In some cases, FDA may prescribe certain labelling
information to be indicated on the label of certain drug
product.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Informations about the recommended dosage,
including initial dose, usual dose, freq. interval,
duration of Tx, dosage adjustment or other pertinent
aspects of drug Tx must be given in full
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Dilution, reconstitution, preparation and administration must
be provided.
Separate directions for adults and children must be stated,
and if not recommended for children, the dosage shall be
clearly identified as “adult dose”.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
If the entire batch is MARKETED UNDER ONE COMPANY,
ONLY THE BATCH NUMBER needs to be indicated.
If batch is divided into several lots are MARKETED BY
DIFFERENT COMPANIES,
the LOT NUMBER and its CORRESPONDING BATCH
NUMBER shall be indicated in every lot.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
BATCH: PLI1-1115-93
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Batch and/or Lot number must be printed on each strip of
ten (10) blister units.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
BATCH: PLI1-1115-93
EXP: 11/15
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
The expiry date shall be expressed in terms of the month
and the year. In such cases, the last day of the month is
assumed as the expiration date.
For a drug that is reconstituted prior to use, a period of
guaranteed efficacy must be specified at a given storage
condition.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
BATCH: PLI1-1115-93
EXP: 11/15
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
The EXP date shall be printed or embossed on the tin foil,
blister and/or strip package.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
BATCH: PLI1-1115-93
Reg: EWDF81238
EXP: 11/15
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Reg. no. shall indicate the drug registration number and
code assigned by FDA
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Mode of administration:
Dose:
BATCH: PLI1-1115-93
Reg: EWDF81238
EXP: 11/15
Store in cool dry place.
60mL
GENERIC NAME salt form
Rx
Brand Name of Some Drug
TABLET
ANTIPYRETIC
Manufactured and distributed by:
Prime Laboratories Incorporated
Km.44 Malolos City, Philippines
Storage conditions appropriate for the product must be
stated
Preliminary period
Requirements for labelling materials of
pharmaceutical products
In addition to requirements stated earlier:
The name and proportion of any antimicrobial agent in
the product
Name any adjuvant in the product or any substance
which, when administered with an antigen, modifies
immune response to that antigen.
Name of species of animal or organism from which the
product has been prepared.
For monoclonal antisera, the name of sp. Source or name
of sp. of origin of hybridoma cell line used in the prep. of
the product.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
In addition to requirements stated earlier:
For viral vac. Produced in animal cells or cell cultures,
the name of the cell culture substrate, or the name of the
species of animal and tissue used in the manufacture of
the product, as well as the name of any residual antibiotic
present in the product when applicable.
Potency of biological products which needs to be
prepared before use.
Potency unit shall be the International Unit, approved by
the FDA taking into consideration current acceptable
standards.
Date of manufacture pertaining to month and year.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
In addition to requirements stated earlier:
Name and quantity of all excipients in the product
except for large volume injections.
Statement of recommended routes of administration.
If antimicrobial agent is not present in the product, the
words “USE ONLY ONCE or DISCARD ANY REMAINING
PORTION” or words to that effect.
Where the contents of the container are to be used in
one occasion only, the words “SINGLE USE” or “SINGLE
DOSE” must be present.
For conc. solution for injection, a direction not to
administer the solution undiluted and directions for
dilution Preliminary
mustperiod
be present
Requirements for labelling materials of
pharmaceutical products
In addition to requirements stated earlier:
Name and quantities of all excipients and AI in the
nominal volume of fluid in the container, listing in
descending order of magnitude.
If there is an amino acid present, a total amount of
nitrogen in the nominal volume of fluid in container.
Nominal osmolality
Statement if the solution is nominally “hypotonic” or
“hypertonic”
Nominal pH of sol’n
Words “SINGLE USE” or “SINGLE DOSE”
Preliminary period
Requirements for labelling materials of
pharmaceutical products
In addition to requirements stated earlier:
Label shall include the name and proportion of any
antimicrobial agent present in product.
Requirements for labelling materials of
pharmaceutical products
Preliminary period
In addition to requirements stated earlier:
The statement “FOR EXTERNAL USE ONLY” printed in
red color must appear on the PDP of the label.
Requirements for labelling materials of
pharmaceutical products
Preliminary period
For products 10mL or less and enclosed in a primary pack.
Label must contain:
Name of product
Company Logo
Strength
Mode of Admin
Batch Number
Expiry Date
Must contain the informations required under general
requirements and specific requirements (sections 2 - 5)
(Name of Product – Injections)
When not practicable to set out particulars in full on a
label on the container, particulars to in 9.1 (in red color)
may be abbreviated, provided abbreviation is not
ambiguous.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Product consist of individual dosage units
Name of product
Company name or logo
Strength
Expiry date
For products in strip or blister packs
Name of product
Strength
Expiry date
must appear every 2 units
Company name and Batch number
every strip of 10 units
Primary pack and other labelling materials must contain
the requirements stated earlier.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
There a container or primary pack containing products is
enclosed in a transparent covering and the particulars
which are required to be set out on the label on the
container or primary pack are clearly visible through the
transparent covering.
Where products are made up or compounded by a
pharmacist in a accordance with the individual
prescription of a medicinal practitioner, dentist or
veterinarian.
Products donated by foreign agencies/person, the
requirements of generic labelling may be waived except
that the expiry date must be indicated.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
The requirements do not apply for drugs used solely for
investigational purpose and donated products by a foreign
agency or person and in exceptional cases where the
labelling provisions of this regulation are not appropriate.
These exemption must be applied for and approved by
FDA in case to case basis.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Manufacture, sale, offering for sale or transfer of
any product that is misbranded.
Forging, counterfeiting, simulating or falsely
representing or using any mark, stamp, label or
other identification device required under the
regulation without proper authority.
The alteration, mutilation, destruction, obliteration
or removal of the whole or any part of the
labelling of the product, if such act is done while
such product is held for sale and results in such
article being misbranded.
Preliminary period
Requirements for labelling materials of
pharmaceutical products
The use on the labelling of any product of any
representation or suggestion that such product is
approved by FDA or that complies with the
provisions of this regulation, when in fact it does
not.
The use, in labelling of product of any reference
to any FDA report or document without clearance
from FDA
Preliminary period
Requirements for labelling materials of
pharmaceutical products
For violation of AO55 s.1988, any or the following
sanctions after due notice and summary hearing
may be imposed by the Secretary of Health
- SUSPENSION or REVOCATION of the LTO of
drug establishments and outlets and cancellation
of Certificate of Product Registration.
- IMPOSITION of ADMINISTRATIVE FINES of
NOT LESS THAN 1,000 Php NOR MORE THAN
5,000 Php
-Recall from the market of misbranded product(s)
-Confiscation of violative product(s)
Preliminary period
Requirements for labelling materials of
pharmaceutical products
The imposition of sanctions stated earlier does not
preclude the institution of appropriate criminal
proceedings pursuant to Section 26 of RA3720, as
amended and Section 12 of RA6675
Preliminary period
Requirements for labelling materials of
pharmaceutical products
Preliminary period
©to
©torespective
respectiveowner
ownerNCII
NCII
Course Orientation,
House Rules and
Pre-laboratory
discussion
Pharmaceutics 2 (PMC2)
BSP 3B
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
Preliminary period
Course Orientation
Syllabus
Requirements
House Rules
Pharmaceutics 2 (PMC2)
Laboratory Rules
BSP 3B
AO 55 s.1988:
Requirements for Labelling
Materials of Pharmaceuticals
WF 14:00 – 17:00
BSP 3C
TTH 10:30 – 13:30
BSP 3F
MS 13:00 – 16:00
BSP 3I
AO 109 s.1969
Prescription Drug
Label Symbol
Preliminary period
TTH 07:00 – 10:00
BSP 3J
MS 07:00 – 10:00
BSP 3L
WF 10:00 – 13:00
AO 109 s.1969
Prescription Drug
Label Symbol
Preliminary period
Prescription Drug Label Symbol
All drugs which requires the prescription of a
physician, dentist, veterinarian or any person
authorized and licensed by law to prescribe must
bear the symbol: Rx
Preliminary period
Rx
Prescription Drug Label Symbol
The symbol must be prominently placed on the
PDP of the label and on any retail carton or
wrapper for such container of each drug or
pharmaceutical specialty.
Preliminary period
Rx
The symbol must be of contrasting color to the
background on which it appears, with no
particular color required and SHALL NOT BE
LESS THAN 50% of the shorter dimension of a
rectangular label or shorter diameter of an
elliptical or nearby elliptical label and NOT LESS
THAN 50% of the area of the PDP for any other
shape of label.
Preliminary period
Prescription Drug Label Symbol
Rx
Overprinting and superimposition is allowed if
the symbol meets the requirements indicated in
these regulations and such overprinting or
superimposition will not result in obliterating or
rendering less legible the other required label
statements.
Preliminary period
Prescription Drug Label Symbol
Rx
For products packed in foil or similar wrapper, the
symbol shall appear on the foil and outer
container from which they are removed for
dispensing.
Preliminary period
Prescription Drug Label Symbol
Rx
For products with an outer retail container, the
placement of the symbol is waived on the
immediate label of the inner container; provided,
however the inner container is not intended to be
sold separately.
Preliminary period
Prescription Drug Label Symbol
Rx
In cases of ampules or other containers too small
or otherwise unable to accommodate the label:
If sold w/o an individual outer container, the
symbol shall appear on the outer container from
which they are removed for dispensing or use
if with an outer retail container, the placement
of the symbol is waived on the immediate label
of the inner container, provided, however, the
inner container is not intended to be sold
separately.
Preliminary period
Prescription Drug Label Symbol
Rx
The symbol is not required on the retail carton or
wrapper if it was easily visible through such
carton or wrapper.
Any drug or pharmaceutical specialty not subject
to the placement of the symbol but whose
labelling bears the symbol shall be deemed to be
misleading.
Preliminary period
Prescription Drug Label Symbol
Rx
Preliminary period
©to respective owner NCII