Audit and compliance

Audit readiness

Reference

https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf

https://ispe.org/initiatives/regulatory-resources/gmp/audit-checklist#

Before start of audit we need to review past audits and note indication of possible problem areas and items, if any ensure that were identified for corrective actions in a previous audit.

If not aware about facility learn what products being produced and how it is organised with personal and function.

To have systematic audit checklist to be prepared and alongwith notebook it needs to be utilised (notebook required to make detailed entries while audit and checklist is to guide auditor).

Atleast three production batches to be selected For thorough analysis to include-

a) Traceability of all components or materials used in that batch.

b) Documentations of raw materials or components, inprocess and finished goods testing for subject product batches.

c) Warehousing and distribution records as they were relate to a possible recall.

1. Selection and training of SMEs- First we need to identify which SME can be presented in front of auditor to avoid or minimize maximum possible risks and in same way need to identify which can pose more risk while interacting with auditor.

Several factors needs to be considered during this evaluation like-

a) Competency in answering investigator questions.

b) Performance under stress.

c) Demeanor and attitude

d) Adaptability

e) New personal

2. Common pitfalls- We need to avoid

a) Common assumption that SMEs are already prepared because participated in previous audits but still they needs to update their skills and practice to answer questions related to current state of subject matter specially anything that is related to risks.

b) Second assumption is person can be SMEs have good knowledge about subject and this can be a problem if person does not have good communication skills and unable to provide clear information in concise manner.

Better strategy is to have knowledgeable person in backroom so they can provide requested information and documentations.

c) Third assumption is that job competence is equal to SME competence. If person is very competent in performing job it is not necessary they possess the skills to encounter with investigator.

The benefits of riskbased approach for preparing SMEs for audit is that is it gives the chances to identify weakness and address those vulnerability, prepare documentations and get your key people ready to represent themselves and company confidentially.