The QC department is tasked with testing raw materials, in-process sample, and finished pharmaceuticals to ensure that they meet the set specifications before any batch gets released into the market.
QC is a crucial element in safeguarding patients. All products leaving a pharmaceutical manufacturing plant are subjected to analytical testing to ensure identity, potency, purity and physical characteristics. If this was not done, faulty or substandard products could enter the hands of patients undetected.
📋 All QC Department SOPs
- How Perform Limit Test for Heavy Metals (SOP)
- How to Perform Solubility Test
- Capreomycin Sulphate Colour of Solution Test – Complete SOP
- Preparation and Standardization of 0.1M Ethanolic Sodium Hydroxide Solution SOP
- Laboratory Color Test Procedure: Step-by-Step Guide
- General Test Procedure to Check Clarity of Sample Solution in Pharmaceuticals
- SOP for Controlling and Storage Reference standards
- SOP for Multi-Stem Thermometer with external sensing probe
- SOP for cleaning, operation, and calibration of Muffle Furnace
- SOP for estimation of Nickel (IS 12122 -1987)
- SOP for Estimation of Sodium (Part 45)
- SOP for estimation of BORON
- SOP on Reference Standards and impurities
- SOP on Working Standards- Preparation, Qualification, Usage, Storage, and Destruction
- SOP on Operation of Fume Hood
- SOP on Procurement, Usage, and Storage of Primary Standards
- SOP for Operation and Calibration of Flame Photometer
- SOP for Operation of Digital Griffin Flask Shaker
- SOP for Monitoring and Recording Critical Environmental Parameters of Different classes
- SOP for Estimation of Mercury using Atomic Absorption Spectroscopy
- SOP on Withdrawal, Storage, Observation & Destruction of Control Sample
- SOP on Receipt and Handling of Laboratory Samples
- SOP on Out of Acceptance Limit in Purified Water System
- SOP on Operation And Calibration Of Karl Fischer Apparatus
- SOP for HPLC Column Cleaning and their Maintenance
- SOP for Operation & Calibration of pH Meter
- SOP for Operation and Calibration of Dissolution Apparatus (Tester)
- SOP for Operation and Calibration of Analytical Balance
- SOP for Operation & Calibration of Water bath
- SOP for Magnetic Stirrer in Pharmaceutical
- Calibration of HPLC and their Operation SOP
- SOP for Operation, Calibration of Electronic balance
- SOP for Glassware Cleaning in QC Lab
- Method Validation of Analytical Procedures | SOP AMV (ICH Q2 (R1))
- SOP for Retesting and Resampling of Raw materials
- Procedure for investigation of Out of Specification (OOS) and SOP Formats
- SOP on Operation and Cleaning of the Decontamination Autoclave
- Annexure for Decontamination Autoclave
- SOP on operation and calibration of autoclave
- SOP on Microbiological Monitoring of Compressed Air
- SOP on Fogging at the Production Floor and Service Floor
- SOP on Checking Balance Eccentric Accuracy
- SOP on Cleaning and Operation of Polarimeter
- SOP on Cleaning Operation Tablet Hardness Tester
- Procedure for Microbial Incubator operation & Calibration
- SOP for Cleaning of Quality control department
- isopropyl Alcohol 70 percentage Preparation SOP
Topics covered in this section
Pharmaceutical QC SOP, analytical procedures, and reference articles for the entire range of lab QC activities. Here you will find GMP aligned documents for Instrument qualification, sampling, calculation guide, and OOS investigation template.
Articles include GMP Requirements for QC Laboratories, Analytical Method Validation (ICH Q2(R1)), SOPs for HPLC and UV-Vis, Dissolution and Disintegration Testing, Microbiological Method SOPs, Water Testing Procedures, Stability Study Procedures, Sampling Plans, Data Integrity Practices, Laboratory Deviation and OOS/OOT Investigation Procedures, and Regulatory Inspection Preparations for the QC Laboratory Function.
FREQUENTLY ASKED QUESTIONS
A: QC tests raw materials, packaging materials, in process samples and finished products, to ensure raw materials are complying with the approved specifications. In addition, it carries out stability studies, investigations of OOS and OOT, and documentation of all laboratory activities as per the GMP requirements.
A: QC laboratories are required to meet standards of US FDA 21 CFR Part 211 Subpart I (laboratory controls), EU GMP Chapter 6 (quality control) and WHO Technical Report Series guidelines. The validation of analytical methods is covered by ICH Q2(R1), computerised systems and electronic data are covered by 21 CFR Part 11 and EU GMP Annex 11. Any procedure should satisfy the data integrity requirements in accordance with the MHRA and FDA guidance.
A: A test result which is not within the approved acceptance range for a product or material is an Out of Specification (OOS) result. Handling must be conducted in a two phase investigation: First a laboratory step to establish whether there is an analyst error or instrument error and then a full production investigation, if the laboratory step is negative. The process is controlled by FDA’s guidance OOS 2006 and is to be fully documented in the batch record system.
A: Yes. The articles are written so that they can be understood by people of all levels of experience. They will be especially useful for students who are preparing to enter the pharmaceutical sector as well as analysts who are new to GMP laboratories for working towards a solid regulatory foundation.
A: Yes. Each QC procedure is not only explained in terms of what to do, but also why it is required from a regulatory perspective. This is useful to complement the formal GMP training programmes. Articles refer to the FDA, EU GMP, WHO and ICH guidance (when applicable), thereby indicating actual regulatory requirements and not simply general best practices.