The backbone of pharmaceutical quality assurance is Standard Operating Procedures (SOPs) and Documents. They specify exactly how the critical tasks need to be carried out, recorded and reviewed in order to meet the regulatory requirements and ensure that safe and effective medicines are delivered to patients.
A GMP regulated facility requires that all critical activities, such as sampling and testing, equipment cleanings, deviations and batch review, to name a few, be documented and approved. This is a system owned by Quality Assurance. QA will be responsible for drafting, reviewing, approving, issuing and retiring of all SOPs and training the staff on each SOP prior to implementation.
📋 QA SOPs List
- Change Control system SOP: Initiation, Review, Assessment, Format, Numbering, Approval and closing
- SOP for Cleaning and Operating of Digital Timer
- SOP on Good Documentation Practices
- Pharma Guideline on How to Prepare SOP (SOP of SOP) with Formats
- SOP on Temperature Mapping in RM, PM, FG and Control Sample Area
- SOP on initiating, incorporating, approval and recording changes to the master documents
- SOP to Initiate, Incorporate, Approve and Record Changes to the Master Documents
- SOP on Change Control / FDA Change Control
- Procedure for Planned Internal Quality Audits in Pharma
- SOP on Collection of Swab and Rinse Water Samples
- isopropyl Alcohol 70 percentage Preparation SOP
- SOP on Storage and Hold Time Study for Products
- SOP for Coding and Calibration of Standard Weight
- SOP for Acceptable Quality Level with Chart Parameters
SOPs in pharmaceutical manufacturing are not voluntary documents. They are required by FDA 21 CFR Parts 211 and 820, EU GMP Annex 11 and Chapter 4, WHO GMP guidelines and PIC/S PE 009. Regulators want site-specific, version-controlled, up-to-date and well understood SOPs.
This section includes SOPs in PDF format and also in an editable MS Word format. All documents are designed to be compliant with the actual GMP expectations and can be used for training, as internal reference, for compliance preparation and audit readiness, in all pharmaceutical departments.
FAQs
Ans: A pharmaceutical QA SOP (Standard Operating Procedure) is a written, approved procedure that details the manner in which a particular GMP activity is performed. It is a requirement of regulations like FDA 21 CFR Part 211, EU GMP Chapter 4 and WHO GMP guidelines.
Ans: The SOPs on this website are drafted in accordance with the key global GMP guidelines such as US FDA, EU GMP, WHO, PIC/S, MHRA etc. These are designed to be used as template references. Each SOP needs to be reviewed, localised to your site specific processes, approved via your document control system and validated to your local regulatory requirements prior to use.
Ans: Yes. The MS Word format (.docx) is available for editing and PDF format is available for reading and reference of SOP on Pharmaguddu.com. The procedure is provided in an editable format so that you can customize the procedure to fit the equipment, processes, terms, and internal numbering system used at your site before approval and implementation.
Ans: These SOPs are prepared for anyone in the pharmaceutical industry – QA, QC Analysts, Production Supervisors, Validation Engineers, Microbiology, Warehouse, Maintenance and Regulatory Affairs. They are also a good companion for pharmaceutical students and GMP trainees, who wish to know how things are organized and documented in the industry.