PPGP Mfg–S&I-S5G5

SCENARIO:

The Non-sterile Liquids Section is scheduled to fill Zinc 20 mg/5 mL Syrup 60 mL into
bottles. Details of the batch for bottling are as follows:

Product name : Zinc 20 mg/5 mL Syrup 60 mL

Primary packaging materials : 60 mL Boston Round Glass Amber bottle with 20

mm white metal cap with Foam-PE Liner

Process : Filling and cap-sealing

Batch Size : 25,000 Bottles

Bottling rate : 60 bottles per minute

Inspection rate: 10 bottles per minute

Packing : 120 bottles per shipping carton

Stacking : 30 shipping cartons per pallet

INSTRUCTIONS:

1> Compute for the number of pallets consumed by the product to be produced.
2> Identify the documents required during sampling and inspection (Documents from
QA and those from Production Line).
3> Identify the PPE and tools to be used for in-process inspection specific to the
production stage indicated. Do not mention PPE and tools that are not related to the
production stage indicated.
4> Prepare a layout of the different quality control status labels to be attached to the
bottled product while awaiting disposition and upon reaching a disposition for the
product. Indicate specific color if applicable.
5> Write the steps for the sampling and in-process testing during filling and cap-sealing
ONLY, including in-process testing area conditions and precautions.
6> Specify the AQL to be used for Critical, Major and Minor defects.
7> Identify the different defects under Critical, Major and Minor defects as applicable to
the material (see Semi-Finished Product Monograph Template).
8> Compute for the total number of samples to be taken during bottling process (filling
and cap-sealing ONLY), number of sampling intervals and sampling frequency.
Identify the basis for the quantity of sample to be taken (use sampling and inspection
tables).
9> Prepare a draft a layout of the assigned semi-finished product identifying the different
inspection points (critical quality attributes).
10> Using the posted Semi-Finished Product Monograph Template, prepare a
semi-finished product monograph showing the different inspection points and
specifications (Provide arbitrary but realistic values or specifications).