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Production and Process Control - Coggle Diagram
Production and Process Control
Documentation
SOPs for critical processes
Ensure products and processes go through the same procedure = predictable results
E.g. Weighing, blending, filling, labelling, packaging etc
Master production and control record a.k.a Master batch record
For each unique formulation and batch size
Contains:
Product name
List of materials
Quantity of each material
Production location
Major production equipment
Production instruction
Safety precaution
Labelling and packaging instruction
Production instruction contains:
Sequence
Process parameter ranges
Sampling instruction
In-process controls
Acceptance criteria
Time limits
Expected yield
Serves as template for batch production and control record
Batch production and control record a.k.a Batch manufacturing record
Contains:
Records of actual process data
Location and equipment used
Test results
Actual yield (Reconciliation)
Personnel that performs the job
Personnel who checks the job
Record of deviations with explanation provided
Conclusion whether final products meet the specs
Copies of labels used are attached
Reconciliation
process to compare the actual quantity of materials used with actual quantity of product obtained (at end of manufacturing process)
expressed as % yield
% yield = Output/Input x 100%
If have significant/ unusual discrepancy observed
must be investigated and accounted for
Charging of materials
General flow
Weigh
record
Double check by another person
Manual
weigh by one person
Verify by another
Automatic
weigh automatically (by machine)
verify by one person
Process Equipment
Must be identified by a distinctive number/ code
No./ code to be recorded in batch production and control record
shows use in production
Equipment and process lines to display
Contents being processd
Stage of process
In-process quality testing
Routine checks on products during manufacturing
ensure product is being manufactured to specification
also enable monitoring and adjustment of process
samples are taken at specific intervals
tested according to established procedure
generally quick and simple tests/ inspection
Time limits
time limits to be established
Start/ Stop time to be routinely recorded
on batch production & control records
For sterile products
Any deviation must be recorded and justified
For completion of each phase of production
Microbial Contamination
SOP to be established and followed
for control of microbiological contamination in products
Examples of some procedures
Sterilisation
require validation
ensure effectiveness
Reprocessing & rework
Reprocessing
taking of material
(in-spec or out-of-spec)
reintroduce it to an existing process
Reworking
Taking of product
(out of spec)
running it through a non-standard process
bring it back to spec
Requires more precaution
uses an unestablished processes
by products may be produced
SOPs to be established and followed
ensure reprocessed & reworked materials conform to specifications
materials can only be reprocess/ rework
after review and approval by QC unit
Production (Line Clearance)
area free from all items used in previous operation
All spillage must be cleaned and cleared
Production equipment have to be properly cleaned
reclean required is equipment is idle for > 2 days
Line clearance record checked by
production manager
supervisor
done before commence of production/ any activity
batch-batch change over
product - product change over
Sampling plan
Written SOPs on how to perform sampling of raw materials, intermediates (bulk mixture), packaging materials and finished products
Number/amount sampled must be representative of lot/batch
Sampling is done by qualified personnel
Ensure sampling can be done effectively and safely
Taking samples
Finished products
Beginning, during and upon completion process
Raw materials
Top, middle and bottom portions without prior mixing
Check for damaged and unlabeled containers
Sampled containers marked and sealed
Information on sample bottle
Name of sampled material
Batch/lot number
Number of the container from which the sample has been taken
Sample number
Signature of the person who has taken the sampling
Date of sampling
Storage conditions
Handling precaution
Sampling device
Must be:
Carefully used and stored
Made of inert material
Cleaned and dried before/after use
Put on masks, gloves and goggles
Packaging & Labelling Operation
Design Considerations
Premises for packaging should be designed and laid out to avoid mix-ups/contamination
laid out in a logical order
according to sequence of operation and cleanliness
Adequacy of working space
Keep labels in secured room
prevent accidental usage
Use tamper-resistant packaging
prevent accidental tampering
Printed and embossed information on packing
should be
resistant to fading or erasing
distinct
Prevent misuse
Before operation
Avoid gang printing of labels
Product name and batch no. displayed at packaging station/line
Avoid close proximity of different products unless there is:
1) Marked differentiation between packaging materials of the products.
E.g. colours, shapes, sizes
2) Physical barriers between the 2 lines
Line clearance
Examine packaging materials and labels for correctness
Check labels for:
Product name
Quality
Batch no.
Expiry/retest date
Warnings (if required)
Storage conditions
Names of manufacturers and suppliers
During operation
Use accumulation tables to prevent mix-up
Cover open hoppers to prevent contamination from environment
Quick labelling after filling and sealing
Labels rechecked at regular intervals
Samples taken should not be returned
After operation
Unused batch-coded labels should be destroyed to prevent accidental use
Reconciliation to check for integrity