Quality Assurance

SOP ON SOP

Change Control

Vendor Qualification

Self Inspection Or Internal Audits

Corrective and Preventive Actions (CAPA)

Training SOP

BMR Preparation and Control

Deviations handling in Pharmaceuticals

Annual Product Review

Preparation and Control of Formats

Job Responsibilities of QA Personnel

Specimen Signatures

Handling of market Complaints

Product Recall Procedure

Handling of Return and Rejected Goods

Master List of SOP

Master Formula Record

Waste Management

Review of Batch Manufacturing Records

Document Control

Maintenance of Old Records

Training on Personnel Hygiene

Line Clearance

Artwork Approval in Pharmaceuticals

Sampling of Nitrogen

Finished Product Release

Documentation errors Correction in Pharma

Shelf life Assignment for the finished products.

Equipment assembly and validation

Medical Examination SOP

Quality systems review by management

Review System for Documents

Spot Checking of Finished goods

In-process control in Pharmaceuticals

Shelf life and storage of sterilized items

Cold chain products handling in Pharmaceuticals

Handling of Regulatory Audits

Handling of Control samples or Reserve Samples

Monitoring of Clean Rooms – Viable Particles by Surface swabs-Sterile area

Rinse water Analysis

Monitoring of Surface swabs in Non Aseptic processing area

Monitoring of the personnel gowning

Evaluation of performance of the Aseptic Processing Area core operators/Microbiologists

Viable Particulate monitoring by MD8 Air sampler for Anaerobic organisms

Monitoring of clean rooms - Viable particles by volumetric air sampling (HI-AIR PETRI) For anaerobic organisms

Finished Product Sampling (Sterile)

Cleaning Validation Calculations-Maximum Allowable Carryover[MACO]

Active Raw Materials calculation for tablets with equivalent factors

Active raw material calculation for tablets without equivalent factors

Review of trends in Environmental monitoring and water

Site Master File in Pharmaceutical Industry

Types of Pharmaceutical waters

Data Integrity in Pharmaceutical Industry (ALOCA+))

HEPA filters in Pharmaceutical Industry

MACO calculation with HBEL(Health-Based Exposure Limits) in cleaning validation

SOP for Preparation of Certificate of Analysis (CoA)

SOP for Cleaning and Usage Procedure of Sampler and Dies

SOP for manufacturing of Placebo or Dummy batches

SOP for Sampling of Granules (Blends), Uncoated Tablets, Coated Tablets and Finished Product

SOP for investigation of product for physical defects

SOP for Assessment of Transit Impact on Drug Product

SOP for Testing and Release Of Product By IPQA at Intermediate Stages

SOP for locating, setting and downloading the temperature Data Logger

Handling of Out of Trend(OOT)

SOP for Stability Program

Intermediate and Finished Product sampling SOP

Acceptable Quality Level (AQL)

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ISPE AUDIT CHECK LIST

Vendor or supplier audit check list