Refer to the picture attached. For the areas to be audited every six months, which area should be audited first why? Explain your answer in terms of risk and impact to the quality of the product if a problem arose.

Transcribed Image Text:

The Audit Team of a pharmaceutical manufacturing company that produces a high volume of fast-moving Liquid Pediatric Oral Dosage forms is preparing their audit plans for the coming year. Part of their plan is the audit of various areas and activities in the plant (internal audit or self-inspection). Risk management is applied during prioritization of areas to be audited to optimize the available resources. The following has been identified as the grouping of areas according to formulation, raw materials and bulk product exposure that may result in contamination, cross-contamination, or mix-up. Based on the conducted risk assessment, the following table was prepared: Table 1. Audit program. PRIORITY NO. 1 2 3 4 5 ITEMS EXPOSED Raw materials, bulk products Bulk products AREAS products Packaging materials, Finished Products, Supplies Non-product- related supplies Dispensing, Compounding, Materials sampling Bottling Semi-finished Labeling and products, finished packaging lines, Semi- FP warehouse, Quarantine, Released materials Engineering and utilities RISK Contamination, cross- contamination Contamination, Every six (6) months cross- contamination Mix-up, Product pilferage Mix-up, Product pilferage Personnel safety, Supplies with AUDIT FREQUENCY Every six (6) months indirect impact to quality of product Every year Every year Every year The Audit Team of a pharmaceutical manufacturing company that produces a high volume of fast-moving Liquid Pediatric Oral Dosage forms is preparing their audit plans for the coming year. Part of their plan is the audit of various areas and activities in the plant (internal audit or self-inspection). Risk management is applied during prioritization of areas to be audited to optimize the available resources. The following has been identified as the grouping of areas according to formulation, raw materials and bulk product exposure that may result in contamination, cross-contamination, or mix-up. Based on the conducted risk assessment, the following table was prepared: Table 1. Audit program. PRIORITY NO. 1 2 3 4 5 ITEMS EXPOSED Raw materials, bulk products Bulk products AREAS products Packaging materials, Finished Products, Supplies Non-product- related supplies Dispensing, Compounding, Materials sampling Bottling Semi-finished Labeling and products, finished packaging lines, Semi- FP warehouse, Quarantine, Released materials Engineering and utilities RISK Contamination, cross- contamination Contamination, Every six (6) months cross- contamination Mix-up, Product pilferage Mix-up, Product pilferage Personnel safety, Supplies with AUDIT FREQUENCY Every six (6) months indirect impact to quality of product Every year Every year Every year

Answer rating: 100% (QA)

Based on the provided information and the risk assessment outlined in Table 1 the area that should b... View the full answer