We support the Pharmaceutical and Bio-pharmaceutical manufacturer in analysing the deficiencies observed by the regulators and responding them with enforced actions. We develop strategic plan to address the action, derive the solutions in a collaborative effort that targeted for practically compliant, achievable and fail proof quality system. It encompasses, but not limited to;
. Assessment of the Warning letter/ Import ban of the Organization between the lines;
. Gap analysis of the facility, quality system, product & process, analytics and knowledge;
. Adequacy mapping of the quality attributes for effective investigation, RCA, Impact analysis, CAPA, and Change management;
. Deployment of quality matrices, Quality Risk and Knowledge Management to bridge the gap appeared in the Warning letter/ Import ban;
. Unit operation and hand-holding of the SMEs to ensure continual enrichment of system and practices by nurturing competency & Team spirit;
. Support to response to the regulatory authority, prepare to face regulatory audit.
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