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Name _______________________ Date ____________________

Section ____________________ Group No. _______________

Exercise NO. 7
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M.O. # __________

MARY IMMACULATE PHARMACY


Fr. Selga St.
Davao City

MANUFACTURING ORDER

Product: GUAIPHENESIN ELIXIR 2% Manufacturing:

Batch Size _________________ Date Started ______________


Batch Number _______________ Date Finished _____________
Expiry Date ________________
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Control Item Ingredients Amount per X –
Number Code # 1000 liters

_______ ______ Guaiphenesin USP 20 kg _________


_______ ______ Alcohol 95% USP 42.105 lit. _________
_______ ______ Methyl Paraben NF 1 kg _________
_______ ______ Propyl Paraben NF 100 g _________
_______ ______ Orange Flavor 40 lit. _________
_______ ______ Glycerin USP
(sp. gr. 1.249) 450 lit. _________
_______ ______ Sucrose 127.5 kg _________
_______ ______ FD&C Yellow # 6 500 g _________
_______ ______ Purified Water,
q.s. 1000 liters _________
_______ ______ 1N Hydrochloric Acid
_______ ______ 2N Sodium Hydroxide
( to adjust pH to 3.0 to 4.0)
_______ ______ ALSOP filter Pads
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Manufacturing Specifications:

1. pH Range = 3.5 to 4.0


2. Use 60 ml Amber Glass Bottle with 25 mm PP caps.

Prepared by _______________ Approved by ___________________


Date ______________________ Date __________________________

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MARY IMMACULATE PHARMACY
Fr. Selga St.
Davao City

MANUFACTURING BATCH RECORD

Product: GUIAPHENESIN ELIXIR 2% Manufacturing:

Batch Size ________________ Date Started ___________


Batch Number______________ Date Finished __________
Expiry Date_______________

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I. SOP PRIOR TO BATCH PROCESSING

1. All ingredients must be checked and approved by Q.C. Prior


to use.
2. All ingredients must be labeled properly. Weights and
volume must agree with the approved M.O.
3. All equipment and accessories must be cleaned.
4. Processing room must be cleaned.
5. Wear necessary protective garments.

II.CLEAN ROOM AND EQUIPMENT CHECK:


Cleaned by Checked by
Liquid Manufacturing Room ---------- ----------
Required Equipment ---------- ----------

III.MANUFACTURING PROCEDURE

1. Pour 300 liters (_______) of Purified Water into a


stainless steel container and heat to 60°C (140°F).
By __________________ Checked by ________________

2. Dissolve Methyl Paraben NF and Propyl Paraben NF in


Purified Water and heat to 80°C (176°F) under stirring for
15 minutes. Check visually for complete solution of the
parabens.
By __________________ Checked by ________________

3. Cool the mixture to 65°C (149°F) under stirring. Then add


Guiaphenesin USP, Sucrose NF, and Glycerin USP one by one
under constant stirring until homogenous and cool to 30°C.

By __________________ Checked by ________________


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Product: GUAIPHENESIN ELIXIR 2% Batch Size______ Batch No._____
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4. In a stainless steel (SS) container, mix 30 liters (______)


95% Alcohol USP and Orange Flavor and add to the mixture.
Rinse the container with the remaining 95% Alcohol USP,
then add the rinsing to the mixture.

By __________________ Checked by _______________

5. In a separate SS container, measure 2 liters (______)


Purified water USP and dissolve FD&C Yellow # 6 thoroughly.

By __________________ Checked by _______________

6. Add the dye solution to the mixture. Rinse the container


with 1 liter (_______) Purified Water USP and combine the
rinsing to the mixture.

By __________________ Checked by _______________

7. Make up the volume to 1000 liters (______) with Purified


Water USP.

By __________________ Checked by _______________

8. Adjust pH if necessary.

By __________________ Checked by _______________

9. Filter the batch until a clear filtrate is obtained.

By __________________ Checked by _______________

IV.BATCH SAMPLING: (Show Computation)

Sample Size __________________

Sampled by ___________________
Date ____________________
Time ____________________
Results ______________________
______________________
______________________

Verified by __________________
Disposition __________________
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Product: GUAIPHENESIN ELIXIR 2% Batch Size______ Batch No.______
________________________________________________________________

V. BATCH RECONCILIATION (Show Computation)

Sample _______________ (___________ %)

Net Yield ____________ (___________ %)

Gross Yield __________ (___________ %)

Loss/ Overage ________ (___________ %)

Computation:

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Role of ingredients in the formulation:

Ingredients Role of Ingredients

Guaiphenesin USP __________________________________

Alcohol 95% USP __________________________________

Methyl Paraben NF __________________________________

Propyl Paraben NF __________________________________

Orange Flavor __________________________________

Glycerin USP __________________________________

Sucrose __________________________________

FD&C Yellow # 6 __________________________________

Purified Water,q.s. __________________________________

1N Hydrochloric Acid __________________________________

2N Sodium Hydroxide __________________________________

ALSOP filter Pads __________________________________