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Production

Kinsela B. Franco
Reagan L. Go
Isabelle F. Ilagan
Natasha R. Jain
Thea V. Vital
1. a. Weighing and Dispensing
DISPENSARY (GRAY AREA) transition from the warehouse (black area) to the
processing area (white area)

METHODS SHALL BE DOCUMENTATION


WRITTEN
OF MATERIALS
(INCLUDING ISSUANCE (WHETHER
HANDLING, WEIGHING, OR NOT THEY ARE
COUNTING APPROVED)
PROCEDURES)
Cont. of Weighing and
Dispensing
ONLY THE MATERIALS
APPROVED BY THE
QC SHALL BE
DISPENSED FOR
WEIGHING

CLEANING OF THE
AREA
-MAKE SURE THE
EQUIPMENTS TO BE
USED FOR WEIGHING
ARE APPROPRIATELY
CALIBRATED

CHECKING OF
MATERIALS TO BE
WEIGHED FOR THEIR
PROPER LABELLING
All materials to WEIGHED
be used shall be MATERIALS
WEIGHING SHALL BE
inside the
weighing area TRANSPORTED
AND STORED
PROPERLY.

CLEAN THE
WEIGHING
CLEAN THE
AND
WEIGHING AREA
AGAIN
DISPENSING
AREA AGAIN
DISPENSED MATERIALS
(RAW, INTERMEDIATE AND
BULK PRODUCTS) SHALL BE
RECHECKED PRIOR TO PROCESSING
DELIVERY TO THE PROD AREA
(SHALL BE DONE BY THE
PRODUCTION SUPERVISOR)
1b. Drug product in Tablet
ORDER OF MIXING FOR TABLETS

Mixing
Milling Drying

Agglomerati
on Mixing
Tabletti
ng
1b. Drug product in Tablet
IPQC
Drug Content Determination evaluate a tablet
potential Content of Granulesfor efficacy, the amount
of drug per tablet to be monitored from tablet to
tablet and batch to batch

Moisture Content of Granules Granules should


possess sufficient strength to withstand normal
handling and mixing processes.
Assay of Active Ingredients
Hardness test for bioavailability poblems that may
arise due to dissolution (Monsato Hardness Tester)
Disintegration Test to test whether the dosage form
disintegrates within the prescribed time
1c. Drug product in capsule
IPQC
Individual weight
determination

Average unit
weight
determination

Disintegratio
n test

Maintenance
of x & R charts
1d. Drug Product in Liquids

IPQC
Clarity

pH

Specific gravity

Final Batch Volume


1d. Drug Product in Liquids

EQUIPMENT
Closed system of production and transfer
Design and installation should provide easy cleaning and
sanitation
High quality stainless steel
Monitored, specified and potable type of water
Easy cleaning of pipework for delivery of ingredients
Calibration should e done regularly
Maintain homogeneity
Maximum period of storage for finished product should be
specified
1d. Drug Product in Liquids (

Order of Mixing (Syrup)


Charge purified water into S/S Tank
Heat to 60 degrees Celsius
Add sorbitol and glycerine. Mix for 10 minutes
Add sodium benzoate. Mix for 5 minutes
Add ferrous sulfate in portions. Mix for 15 minutes.
Maintain temperature at 50-60 degrees Celsius
during mixing.
Cool the compounding tank to 40 degrees Celsius
Add flavorant and Q.S. Ad colorant
Filter solution if necessary
1e. Drug Product in Semi-Solid

IPQC
Active material dispersion/ solubilization

pH (Except ointment)

Viscosity
1e. Cont.

Equipment
Closed system of production
Minimum dead legs
High quality stainless steel
Water shall be of potable quality and have an acceptable
microbial count before use
Pipelines easily dismantled and cleaned
Dipsticks are used and should be calibrated, made of suitable
non-reactive and non absorption material
1f. Drug Product in Sterile Product
IPQC
1f. Drug Product in Sterile Product
Equipment
Suitable mixing vessel
Sterilizers
Air-filtration systems
Water treatment systems
Warning system (failure in the air supply and
pressure difference)
1f. Drug Product in Sterile Product
Order of Mixing
Solute is added to the solvent in a mixing
vessel
Stir until dissolution is achieved
Apply heat if the solute is more soluble in
elevated temperatures
Solutes having low concentrations are pre-
dissolved in small volumes of solvent and
eventually added to the bulk
2. Important processing steps done prior, during and after processing:

A.) Prior:
All employed in processing shal be checked before use.
All materials utilized in processing shall be checked for its
identity and weight against the batch record before use
Ensure that working area and equipment are free from any
material product that is not required for current operation
All equipment should be clean before operation
B.) During:
- All operation shall be performed in accordance with the written
procedures. Any deviation shall be justified and reported
- Particular attention shall be given to the possibility of cross-
contamination.
- All containers and equipment holding intermediate products
shall be properly labaled as to identify the material and stage of
C.) After:
All in-process intermediate and bulk controls shall be accurately
recorded at the time of performance . All step-wise activities in the
processing operation indicated in the batch processing record shall
be signed and dated at the time of completion of the activity
3. Dead-legs on piping system

Dead leg is a length of pipe leading to an outlet which has been removed
or is rarely used or unused entirely. These sections of process piping
therefore become isolated and no longer maintain a regular flow of water.
Dead legs are often formed in both industrial and domestic process piping
as processed are changed or modified.
4. documents needed in production
Specification
Raw material specification
Packaging material specification
Specification for intermediate products, bulk product, and finished
product

Production documents
- Master batch production record
- Master processing production record
- Master packaging production record
- Batch processing record
- Batch packaging record
Quality control documents
Procedure for sampling
Test method
Record of sampling
Record of analysis and test report

Warehouse and distribution documents


- Inventory card
- Record of distribution of finished product

Document for maintaining, cleaning, monitoring of manufacturing


areas and equipment
- Procedure and record for maintenance and cleaning of equipment
- Procedure and record for cleaning of manufacturing areas
- Procedure and record for pest control
- Procedure and record for monitoring airborne particle and microorganism
Documents for specific equipment
Procedure for opening a specific equipment
Procedure and record of calibration of a specific equipment

Procedure and record of self- inspection


Guidelines and records of personnel training
Document for production complaints, recalls, returned and destruction of
product
- Procedure and record for returned product
- Procedure and record for product recall
- Procedure and record of destruction of rejection materials or product
5. Key difference in what is practiced in the
industry and learnings from the school

The application of knowledge distinguishes the practice in the


industry and the learning acquired from the school. The former
deals with a more hands-on approach on the integration of
techniques and is more strict when it comes to the
establishment of values. On the other hand, the latters
approach is mostly theoretically derived.