Study Set Content:
A receiving tally report should be prepared; information indicated in a RTR is as follows:
- Pre-printed data
- Information to be supplied by:
A. Warehouse
B. Quality Control
Are the ingredients intended for use in manufacture of drugs and cosmetics, including those that may not appear in the final product.
raw materials
- QC inspector will check the RTR.
- Each container is visually examined carefully for damages.
- Adequate number of samples are taken from representative containers
Reception
- The inspector checks the raw material container has a “hold” or quarantine sticker pasted by a warehouse personnel to indicate if the material is subjected for acceptance or rejection.
- Samples are submitted to the laboratory for testing.
- The sample is subjected to tests such as:
physical and organoleptic examination
identification tests
limits of impurities
potency or assay
microbiological tets
- If the raw materials meet with monograph specifications it is “approved” for used. Otherwise it is rejected.
- Decision stickers (approved or reject) are issued by the QC department. The decision sticker is placed on the top of the quarantine sticker.
- Materials will then be sending to either rejected or approved areas.
Quarantine
The inspector checks the raw material container has a
“hold” or quarantine sticker
- The sample is subjected to tests such as:
- physical and organoleptic examination
- identification tests
- limits of impurities
- potency or assay
- microbiological tets
They will be transferred to the rejected area to prevent the possibility of use in any procedures.
Rejected Materials
- It is brought to the approved materials area
- Materials are tested when re assay date is due.
- Materials are further audited to make sure that they are rotated in a first in, first out order (FIFO).
Approved materials
Requires thorough investigation of any unexplained discrepancy whether or not the batch has already been distributed.
Production Record Review
auditing of packaging and labeling operation falls on the
Inspector
The auditing of packaging and labeling operation falls on the inspector.
Packaging control
The auditing of packaging and labeling operation falls on the inspector. These operations are controlled for the following reasons:
- To assure that only those products that have met the standards and specifications established in the master formula records shall be distributed to the market.
- To prevent mix-ups
- To assure correct labelling and labelling materials.
- To assure that the finished product is properly identified with appropriate control.
Mix ups and errors are prevented by the following measures:
- Facilities are cleared out of package finished products and packaging materials
- Products which has a similar appearance, containers or labels are not processed simultaneously on adjacent or nearby lines
- Proper reconciliation is done after the packaging is completed
- direct contact with the product
- bottles, tubes, ampules
Primary packaging components -
- do not come in direct contact with the product and serve as accessory
- labels, inserts
Secondary packaging components
Includes all written, printed or graphic materials accompanying a product.
Printed materials
- Text
- Color
- Size
- Thickness
- Grain direction
- Sealability
- Cleanliness
- Surface finish
- Adequate paste
- Shape
Criteria for acceptance of printed materials:
- name of drug or cosmetic
- strength or quantity of the substance
- Lot or batch number
- expiration date
- registration number
- storage condition
- name of the manufacturer
- business address
- quantity of the components in preparation
- quantity of the components of package
- Rx symbol if needed
- warning
- adequate direction
Labeling Controls requirements
- shape
- volume
- finish
- opening
- diameter
- height
- shape
- thickness
- color
- clarity
- leak
- torque
- peeling
- cleanliness
- light transmission
- stress crack resistance
Container Controls
Physical inspections include the following criteria
- identification
- infra-red properties
- thermal analysis
- extractable substance
- non-volatile residue
- water vapor permeation/ transmission
- moisture
- resistane to water attack
Physio-chemical tests for containers
