PRODUCTION
AJAYI, CUANZON, DE LEON, DECAMPONG, ENCINARES, LEGASPI, NUYDA
Schematic diagram o the processing steps
involved on Section 6 of the cGMP
1. Receiving of raw materials, packaging
mat, intermediate and bulk products
2. Documentation for proper labelling
from QC
3. Weighing and dispensing using clean
equipment in a clean environment
conditions
4. Weighing measuring operations done
by two person who independently
verify the correctness of the identity
and amount of weighed measured
materials
5. After weighing, dispensing and
labelling the materials products shall
be transported and stored in manner
that will preserve its integrity until
further processing
6. Dispensed materials shall be
RECHECKED for IDENTITY, ACCURACY
and is to be signed by the
PRODUCTION SUPERVISOR
7. Deliver to warehouse
GRAY AREA
 Transition from black(storage) to white
(processing) area where reduction of
transfer of contaminants is achieved
 Only approved materials permitted
Important Processing Steps Done Prior, During,
and After Processing
A.Prior
 Check if all the materials to be used in
the production has the correct identity
and weight based on the batch record.
 Packaging materials like containers and
closures to be used should be clean and
prevents leakage, contamination, and
deterioration.
 Before the start of production, check if
all the equipment is in good condition
and is properly calibrated.
 Intermediate and bulk products to be
used should be properly labelled.
B.During
 Release accurately all in process
intermediate and bulk controls.
 To prevent the possibility of cross-
contamination, proper care and
attention must be given to all stages of
production.
 Documentation of all the steps.
C.After
 Release accurately all in process
intermediate and bulk controls.
 To prevent the possibility of cross-
contamination, proper care and
attention must be given to all stages of
production.
 Documentation of all the steps.
DEAD LEGS (on piping system)
 A 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
Documents needed in production based on
Section 10 of cGMP
1. MASTER BATCH PRODUCTION RECORD
 It should include the product name,
dosage form, strength and description,
the writer’s name and department, name
of verifier and list of document
distribution.
2. MASTER PROCESSING/PACKAGING
PROCEDURE
 Is a document from which copies are
made for use in the
processing/packaging of individual
batches of products
3. BATCH PROCESSING/PACKAGING
RECORD
 Reproduced from its master
processing/packaging procedure and
shall be checked for accuracy, dated and
signed by the production manager