SOP for QMS Tools

SOP for QMS Tools

Document Management –Review batch records, stability reports, validation reports, and associated documents required to comply with respective regulatory country GMP.

Site Deviations – initiation, investigation, review, closeout, and maintenance for internal and external issues.

Change Controls – initiation, review, closeout, and maintenance of all internal and external change controls.

CAPA Management – manages CAPA and Investigation Program and ensures that CAPAs based on investigation of deviations, complaints, change controls, and audits are closed in a timely manner.

SOP Management – GMP-related SOPs, ensure they are followed, and meet current corporate and regulatory requirements.

Validation and Qualification Management – To review and approved design, validation, and implementation activities, Review validation protocols and reports, equipment/facility change requests, and calibration documentation for any new change control requests associated with plant operations.

Complaints – Provides QA support for complaint investigations and Ensures investigations are properly reviewed with respect to the root cause, CAPA requirements, and their evaluation.

Returned Goods Management – Manages the QA portion of the returns process per site SOP.

Warehouse Management- Co-ordinate warehouse QA activities for incoming inspection and release based on determining priorities and Participate in all recall actions as required with regards to inventory management and documentation.

Training Management –

Risk Assessment Management – Establish and maintain a risk management program and risk registrar tracking tool.

Self-Inspection and Inspection Readiness Program

  • Develop new procedures and update current procedures to ensure that they reflect current practices and pharmaceutical industry best practices.
  • Manage assessments/gap analysis of the quality systems and design, develop and execute effectiveness measurement metrics and tools
  • Review Track wise records for QA related activities such as UPD / Lab event / OOS / OOT / change control / CAPA and verification of action items

About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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