The Personnel and Administration (P&A) or HR department in a pharmaceutical company is far more than a support function. It is at the heart of GMP compliance. HR is involved in procedures that govern every person that comes in to a manufacturing facility, touches a product, or signs a document.
P&A is responsible for employee onboarding, GMP Training Programs, Personnel Hygiene Controls, Health Monitoring, Dress Code Requirements and Access Authorization. These activities directly affect the quality of the product and patient safety. An undocumented health assessment or poorly trained operator can be an observation in an FDA, EU GMP or WHO inspection.
📋 P&A | HR SOPs list
- SOP for Cleaning of Vacuum Cleaner
- SOP on Recruitment of Employees by HR
- SOP on Pest & Rodent Control
- SOP on Disposal in Tablet Department
- SOP for Footwear Cleaning in Pharmaceutical
- SOP on Sanitizing Solution Preparation
- SOP on Handling Scrap and Disposal in Pharmaceutical
- Entry and Exit Procedure for staff, visitors in Pharmaceuticals
- Entry exit Procedure in Pharma SOP
- SOP on Training of Personnel in Pharmaceutical Industry with Formats
HR SOPs outline the processes and procedures for hiring, training, assessing, and recording employees during their time at the company. They establish standards for conduct within controlled manufacturing areas; maintain personnel qualification documentation that is audit ready; provide cross-departmental liaison between QA, Production and Validation.
Frequently Asked Questions (FAQ)
Ans: Pharmaceutical P&A/HR SOP is a written procedure that outlines how people-related activities need to be performed in a GMP environment. This involves training, health checks, dress code and record keeping.
Ans: The qualifications and responsibilities of personnel are addressed in FDA 21 CFR Part 211 Subpart B. EU GMP Chapter 2 provides in detail requirements for personnel. There are equivalent sections of WHO GMP and PIC/S guides. ICH Q10 also addresses competency of personnel in the Pharmaceutical Quality System.
Ans: The SOPs and templates presented in here are written in the nature of GMP aligned Reference Document. They are tailored to align with regulatory requirements and industry standards. All SOP however should be carefully reviewed and modified to suit individual processes, equipment, site layouts and quality management systems before use in any facility.
Ans: SOPs that are provided in pdf format should be used for reference purposes only and should be readable, printable and shared. MS Word format SOPs can be edited to meet your facility’s needs, include your company logo, change version numbers, and go through your document control system for approval.