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Pharmaceutical Laboratory Policies Guide

The document outlines various policies for a pharmaceutical dosage form laboratory. Key policies include: - Students must wear complete laboratory attire during compounding or they will not be allowed to work. - Students caught doing group work on weighing ingredients or compounding will not receive credit for the preparation. - The use of mobile phones, tablets, laptops and other gadgets is strictly prohibited unless authorized by the professor. Students caught using gadgets will receive a zero for the day's preparation. - Strict policies are outlined for labeling, packaging, submissions, attendance and other areas to ensure safety and quality in the laboratory. Rubrics are provided to grade preparations and reports.

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Fersan Angeles
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0% found this document useful (0 votes)
20 views78 pages

Pharmaceutical Laboratory Policies Guide

The document outlines various policies for a pharmaceutical dosage form laboratory. Key policies include: - Students must wear complete laboratory attire during compounding or they will not be allowed to work. - Students caught doing group work on weighing ingredients or compounding will not receive credit for the preparation. - The use of mobile phones, tablets, laptops and other gadgets is strictly prohibited unless authorized by the professor. Students caught using gadgets will receive a zero for the day's preparation. - Strict policies are outlined for labeling, packaging, submissions, attendance and other areas to ensure safety and quality in the laboratory. Rubrics are provided to grade preparations and reports.

Uploaded by

Fersan Angeles
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd

Pharmaceutical Dosage

Form Laboratory

LABORATORY POLICIES
Laboratory Policies
1. Students must wear their complete
laboratory attire during
compounding.
NO COMPLETE laboratory attire,
NO WORK POLICY will strictly
implemented
Laboratory Policies
2. Students caught doing a group
work on weighing of ingredients
and compounding will not get any
credit for the preparation
Laboratory Policies
3. The first member of the group will
order the labels and auxiliary
labels using the requisition form.
 ALWAYS check your labels
before signing the “received”
portion of requisition form to avoid
demerits.
Laboratory Policies
Phar 3 Laboratory
Order Form
Section: ____ APPENDIX H: ORDER
Group no. ____ FORM
Members (surnames):

Label (indicate quantity):


____ white
____ red
____ shake well
____ poison label

Received by:

Signature over surname


Laboratory Policies
4. Use any gadgets like mobile phones,
tablets, laptops, and the like, unless
otherwise authorized by the professor
is strictly prohibited.
 Students caught using any gadget will
automatically get a grade of ZERO for
the day’s preparation.
Laboratory Policies
5. Use of friction pen for preparation
labels and answering exams is
NOT allowed.
 Its use will give the student a mark
ZERO.
Laboratory Policies
6. Any mislabeled preparation will get
ZERO.
Laboratory Policies
7. For a twice a week meeting, the
number of allowable absences - 7
times. For tardiness – 3 x is
equivalent to 1 absence.
 More than 7x – the student will be
marked FA.
Laboratory Policies
8. For absentees with valid excuse
letter/with medical certificate they
will be allowed to make up their
missed preparation only on the
day of their return to Dosage Form
class.
Laboratory Policies
9. The maximum point the absentee
will get for the preparation is only 3
per item in the RUBRICS.
Laboratory Policies
10. For absentees during major exams with
valid excuse letter/with medical certificate,
they will be allowed to take special exams
only during the first meeting upon their
return.
 For students who will be absent during
FINAL EXAMS, the scope will be
comprehensive. “COVER to COVER”
Laboratory Policies
11. For missed quizzes, the remedial
will be at the Professor’s
discretion.
12. Invalid absence will not allow the
students to make up any
preparation.
Laboratory Policies
13. Strictly NO borrowing of
calculator during exams. Cell
phones or any similar gadgets will
not be allowed to be used as
calculators.
Laboratory Policies
14. For students who will go out to
attend to their personal
necessities, they should log their
name and the time they left and
returned in the lab into the log
book taken care of by the class
president.
Laboratory Policies
15. The earliest time a student can
leave the class is thirty minutes
prior to the end of the class.
Unless otherwise classes will be
suspended.
Laboratory Policies
16. Make sure the working area is
clean before leaving to avoid
demerits.
17. NO visitors for the students
should be entertained during the
lab hours, EXCEPT for the official
calls for the president.
RUBRICS
PART 1:
COMPOUNDING
RUBRICS: COMPOUNDING
 Compounding Skills and Practices
1. Actual Compounding
 Observed ALL of the following instructions
A. Use of prescribed oil cloth
B. Use of trash bin
C. Use of unlined weighing boxes
D. Use of clean spatula for solid ingredients
E. Proper pipetting for liquid ingredients
RUBRICS: COMPOUNDING
2. Post Compounding skills
 Observed ALL of the following instructions
A. Clean weighing/reagent area after the
experiment
B. Clean working areas
C. Arranged chairs after the experiment
D. Safety disposal of waste
 For group work
 Worked in cooperation with group mates
RUBRICS: COMPOUNDING
4 Followed ALL actual compounding instructions;
Observed ALL post compounding instructions;
worked in cooperation with group mates
3 Did not follow at least one (1) compounding
instruction; Follow ALL post compounding instructions

2 Did not follow two (2) compounding instructions;


Follow ALL post compounding instructions; worked in
cooperation with group mates

1 Did not follow three (3) compounding instructions; Did


not follow at least one (1) instruction.
RUBRICS: COMPOUNDING
 Compounded Products/Preparations
 With appropriate
A. Organoleptic Appearance
B. Volume/Weight Content
RUBRICS: PRODUCT/PREPARATION
4 With appropriate organoleptic appearance;
With appropriate volume and weight
3 ________________

2 ________________

1 NOT appropriate organoleptic appearance; or


not appropriate Volume and Weight
RUBRICS: COMPOUNDING
 PACKAGING
 Observed ALL of the following instructions
A. Proper Container
B. Neat and Clean
C. No container defects
D. Bottles (with cap liner)
E. Ointment jar, Pastilles and Pill containers (lined with
glassine paper)
F. Paper tabs (properly folded and envelope with V – cut and
standard size
G. Sprinkle top containers (body lined with bond papers)
RUBRICS: PACKAGING

4 Observed all of the packaging instructions

3 Did not follow one (1) instruction

2 Did not follow two (2) instructions

1 Did not follow three (3) instructions


RUBRICS: COMPOUNDING
 LABELING
 Observed ALL of the following instructions
A. Labeling techniques are properly observed
(Non wrinkles, pasted well, aligned label,
border lines properly cut)
B. Clean label
C. Correct ingredients
D. Correct amount of ingredients
E. Auxiliary label if applicable
RUBRICS: LABELING

4 Observed all of the packaging instructions

3 Did not follow one (1) instruction

2 Did not follow two (2) instructions

1 Did not follow three (3) instructions


RUBRICS: COMPOUNDING
 Time of submission of Extemporaneous
Product/Preparation
A. On or before the allotted time
RUBRICS: TIME SUBMISSION

4 On or before the allotted time

3 Late for 5 minutes

2 Late for 10 minutes

1 Late for more than10 minutes


FORM – COMPOUNDING
(maximum of 20 points)
Date: Prep No: Title :
Yr. & Sec: I. Compounding II. Product III. Packaging IV. Labeling V. Time of TOTAL
Skills & Practices Submission
Group. No.
MEMBERS

1.

2.

3.

4.

5.

6.
RUBRICS
PART 2:
LABORATORY REPORT
Preparation No.1 Divided Powders
Parts of the REPORT PARTS of the REPORT
I. Category VI. Computations
II. Synonym/s VII. Label
III. Description of the VIII. Container
Final Product
IV. Use/s POST LAB QUESTIONS
V. Formula
a. Ingredients
b. Original amount
c. Computed amount
RUBRICS: Laboratory Report
 Completeness of Report
 Accuracy of Information
 Neatness of Report
 Time of Submission - REPORT
RUBRICS: Completeness of Report
5 Completely answered

4 One (1) portion of the report was unanswered

3 Two (2) portions of the report were


unanswered
2 Three (3) portions of the report were
unanswered
1 More than (3) portions were unanswered
RUBRICS: Accuracy of Information
5 No mistakes

4 One (1) mistake

3 Two (2) mistakes

2 Three (3) mistakes

1 More than three (3) mistakes


RUBRICS: Neatness of Report
5 No Erasures

4 With one (1) erasure

3 With two (2) erasures

2 With three (3) erasures

1 With more than three (3) erasures


RUBRICS: TIME SUBMISSION
5 On or before the allotted time

4 Late for 5 minutes

3 Late for 10 minutes

2 Late for 15 minutes

1 Late for more then 15 minutes


FORM – LABORATORYREPORT
(maximum of 20 points)
Date: Prep. No: Title :

Yr . & Sec: Completeness of Accuracy Neatness Time of TOTAL


Report of Report Submission

Group. No.

MEMBERS

1.

2.

3.

4.

5.
GRADING SYSTEM

 LONG EXAMS = 40%


 QUIZZES = 30%
 Prep/Reports = 30%
100 %
INTRODUCTION
LABELING
 Containers: Bottle/Ointment
jars
 Classification:
 Shape: Round; Blake
(rectangular)
 Color: Flint (colorless); Amber
(brown/light resistant)

By: Nelson T. Tubon


INTRODUCTION
Containers

By: Nelson T. Tubon


Label
 Main label
 White – For internal use
 Red – For external use
 Back Label
 White – Gum label
 Auxiliary Label
 Shake well – to be place below/side of the main
label
 Storage condition
 Poison label – skull & vignette

By: Nelson T. Tubon


Sample Label
UST Pharmaceutical Laboratory
Manila, Philippines
Date: Year & Section:

Dr. _____________ No. _____

Rx
_______________________
_______________________
_______________________

Shake well

By: Nelson T. Tubon


Sample Label
day/month/year
(2 digits)
UST Pharmaceutical Laboratory
11/08/15 Manila, Philippines
Date: Year & Section:

Dr. _____________ No. _____

Rx
_______________________
_______________________
_______________________

Shake well

By: Nelson T. Tubon


Sample Label
2DPh
Group #
UST Pharmaceutical Laboratory Member #
Manila, Philippines (V-3)
Date: 11/08/15 Year & Section:

Dr. _____________ No. _____

Rx
_______________________
_______________________
_______________________

Shake well

By: Nelson T. Tubon


Sample Label
UST Pharmaceutical Laboratory
Manila, Philippines
Date: 23/07/14 Year & Section: 2D Ph
Dr. TUBON, N. V-3
Preparation
No.
Dr. _____________ No. _____

Rx
_______________________
_______________________
_______________________

Shake well

By: Nelson T. Tubon


Sample Label
UST Pharmaceutical Laboratory
Manila, Philippines
Date: 23/07/14 Year & Section: 2D Ph
Rules in Labeling: V-3
[Link] abbreviations
Dr. TUBON, N. [Link] latin terms No. 1
[Link] amount is less than 1 g ->
mg ; 1mL -> drops
Rx
_______________________
_______________________
_______________________

Shake well
Sample Label

UST Pharmaceutical Laboratory


Manila, Philippines
Date: 23/07/14 Year & Section: 2D Ph
V-3

Dr. TUBON, N. No. 1

Rx ALUMINUM HYDROXIDE GEL


Aluminum Hydroxide ....................... 326. 8 g
Sorbitol ............................................ 282.0 mL
Syrup ............................................... 93.0 mL
H20, q.s ad ....................................... 1000 mL
Shake well

By: Nelson T. Tubon


Sample Label
UST Pharmaceutical Laboratory
Manila, Philippines
Date: 23/07/14 Year & Section: 2D Ph
Name of Preparation V-3
[Link] Prep – standard
Dr. TUBON, N. reference (USP)*** No. 1
[Link] Prep – SRB
3.*** UNDERLINE
Rx
_______________________
_______________________
_______________________

Shake well

By: Nelson T. Tubon


Sample Label
UST Pharmaceutical Laboratory
Manila, Philippines
Date: 23/07/14 Year & Section: 2D Ph
V-3

Dr. TUBON, N. No. 1

Rx
SIMPLE SYRUP NF 34

By: Nelson T. Tubon


Sample Label
UST Pharmaceutical Laboratory
Manila, Philippines
Date: 23/07/14 Year & Section: 2D Ph
V-3

Dr. TUBON, N. No. 1

Rx ALUMINUM HYDROXIDE GEL


Aluminum Hydroxide ....................... 326. 8 g
Sorbitol ............................................ 282.0 mL
Syrup ............................................... 93.0 mL
Add water............................... ………1000 mL

By: Nelson T. Tubon


Shake well
BACK LABEL
 Gum label
 No duplication of color
 Color coding (per group)
 Size: 1.5 cm x 1.5 cm

2DPh 2DPh
TUBON TUBON, N.
V-3 V-3

By: Nelson T. Tubon


INTRODUCTION
LABELING
 Containers

By: Nelson T. Tubon


Example : Principal Display Panel

1X
UST Pharmaceutical Laboratory
Manila Philippines UST Pharmaceutical Laboratory
Date: 23/07/14 Yr. & Sec. 2DPh Manila Philippines
V-3 Date: 23/07/14 Yr. & Sec. 2DPh
Dr. TUBON, N. No. 1 V-3
Dr. TUBON, N. No. 1
Rx
ALUMINUM HYDROXIDE GEL Rx
ALUMINUM HYDROXIDE GEL

2X
Example: Back Label

2DPh 2DPh
TUBON TUBON
V-3 V-3
INTRODUCTION
PAPER ENVELOPE
 Measurement
8 cm 8 cm

1 cm
12 cm

17 cm
By: Nelson T. Tubon
INTRODUCTION
PAPER ENVELOPE
 Step 2

Paste

By: Nelson T. Tubon


INTRODUCTION
PAPER ENVELOPE
 Step 3

BACK LABEL

By: Nelson T. Tubon


INTRODUCTION
PAPER ENVELOPE
 Step 4
FOLD at least 1 cm

MAIN LABEL

By: Nelson T. Tubon


INTRODUCTION
PAPER ENVELOPE
 Step 5
FOLD 1 more time

MAIN LABEL

By: Nelson T. Tubon


INTRODUCTION
PAPER ENVELOPE
 Step 6

FOLD both sides

MAIN LABEL

By: Nelson T. Tubon


INTRODUCTION
PAPER ENVELOPE
 Step 7

 Attached label on
the principal display
Rx panel (FRONT)

By: Nelson T. Tubon


INTRODUCTION
PAPER ENVELOPE
 Step 8

 Attached back label


TUBON
2 DPH
I–3

By: Nelson T. Tubon


STEPS IN THE FOLDING OF
POWDER PAPERS

1
8 cm

13 cm
 The powder papers may be of any convenient size to hold
the amount of powder required
STEPS IN THE FOLDING OF
POWDER PAPERS

 FOLD toward you a uniform flap of about 0.6 cm of the long side
of the paper
PLACE the weighed or divided amount of powder in the center of
each paper
STEPS IN THE FOLDING OF
POWDER PAPERS

 Be careful not to disturb the powder excessively, bring the


lower edge of the paper upward, and place it proximate to the
crease of the flap
STEPS IN THE FOLDING OF
POWDER PAPERS

 Grasp the flap, press it down upon the tucked-in bottom


edge of the paper and FOLD again with an amount of paper
equal to the size of the original flap (0.6 cm)
STEPS IN THE FOLDING OF
POWDER PAPERS

 FOLD the paper carefully by not disturbing the position of the


powder into 3 equal parts to form a crease on each end of the paper
STEPS IN THE FOLDING OF
POWDER PAPERS

Lift the other folded end and insert the other end to
form a sharp crease so that powder cannot escape
STEPS IN THE FOLDING OF
POWDER PAPERS

 Have a uniform folds, and should be of uniform length and height


 There should be no powder in the FOLDS and none should be
capable of escape with moderate agitation
STEPS IN MAKING ENVELOPE
9 cm

1 8 cm

12.5 cm 1 cm

17 cm
STEPS IN MAKING ENVELOPE

2 FOLD at least 1 cm
STEPS IN MAKING ENVELOPE

3 FOLD 1 more time


STEPS IN MAKING ENVELOPE

4 FOLD BOTH SIDES


STEPS IN MAKING ENVELOPE

5  Attached label on
the principal display
panel (FRONT)

 Attached back label


List of Requirements
CLASS
1. Plastic cups
2. Gum label
3. Plastic spoon
4. Trays (1big, 1 small)
List of Requirements
GROUP
1. Half gallon empty ice cream can
2. Rags
3. Lighter/Match
4. Tissue
5. Hand Towel
6. Liquid soap
7. Good quality padlocks
8. Glassine paper
9. Weighing paper boxes
List of Requirements
INDIVIDUAL
1. Pair of scissors
2. Good quality glue
3. Oil cloth (2.5 ft. x ft.)
4. Lab Gown – violet color with dept. seal
5. Head cap
6. Containers

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