| Instrument Calibration | As per SOP | Yearly (±30 days) | As per SOP |
| Type A Cleaning | Visual Inspection | Batch to Batch or after 10 batches | As per SOP |
| Type B Cleaning | Visual Inspection | Product to Product |
| UV Verification |
| Control Sample Verification | Appearance (All dosage) | After every 6 months (±7 days) Control sample shall be kept for Expiry + year | Schedule M of Drug & Cosmetic Act |
| Bulging in Strips (Tablets & Capsules) |
| Obnoxious odour (All dosage from) |
| Leakage(All dosage form) |
| Solidification of powder (DPI) |
| Cake formation (Sachet) |
| Layer separation (Liquid) |
| Balance Verification | Bubble of Spirit level shall be at centre | Daily | In-House |
| Balance Calibration | Accuracy | Monthly (±3 Days) | USP <41> USP <1251> |
| Linearity |
| Precision |
| Corner Load |
| Weight Calibration | By outside party | Yearly (Outside Party) | As per SOP |
| Temperature /RH | Data loggers kept at worst locations | Initially and after every 4 hour | As per VMP & respective protocols |
| Equipment Qualification (Oral) | Sampling done from worst case locations | 3 & 5 Years (±1 month) |
| Equipment Qualification (Ointment) | 2 & 5 Years (±1 month) |
| Equipment Qualification (Parentreral) | 6 months, 1 year & 2 Year (3 & 5 Years (±1 month) |
| Autoclave Qualification (Parenteral) | Heat Distribution & Penetration study in Load Chamber | 1 Year (- 1 month) | HTM 2010 Part 3 Volume4, EU GMP, Annex 4 PDA Technical Report 01 Schedule M WHO TRS 961, 2011, Annex 6 USP <1229> BS EN 285: 1997, ISPE, ASTM |
| F0 Calculation |
| Determination of SAL & SLR |
| Biological Challenge Test |
| Area Qualification /HVAC | Air Change rate | Half Yearly | Schedule M |
| PAO test | Yearly | Schedule M |
| Non-Viable Particle Count | Yearly | Schedule M & ISO 14644 |
| Air Flow Pattern | 2 Year | ISO 14644 |
| Recovery Test | 2 Year | ISO 14644 |
| Viable Particle Count | Yearly | Schedule M |
| Differential Pressure | Yearly | Schedule M |
| Temperature &RH | Yearly | Schedule M |
| AHU Duct Design | Duct Leak Test | During Initial Qualification or Whenever any change | ASHRAE, ASTM, SMACNA |
| Duct Design |
| Purified Water System | Description | Initially | Indian Pharmacopoeia & In-House |
| Conductivity |
| Total Organic Carbon /Oxidisable Substance |
| Acidity/Alkalinity |
| Nitrates |
| Heavy Metals |
| Microbial Count |
| Pathogens (Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus) |
| Water for Injection | Description | Initially | USP 39 & IP |
| pH |
| Acidity & Alkalinity |
| Nitrates |
| Total Organic Carbon/Oxidisable Substance |
| Conductivity |
| Microbial Count |
| Bacterial Endotoxin Test |
| Compressed Air | Oil Content | Yearly | ISO 8573 |
| Moisture Content |
| Carbon Dioxide |
| Carbon Mono Oxide |
| Sulphur Dioxide |
| Hydrocarbons |
| Nitrogen Oxide |
| Dew Point |
| Non- Viable Particle Count |
| Viable Particle Count |
| Nitrogen | Oil Content | Half Yearly | ISO 8573 |
| Moisture Content |
| Carbon Dioxide |
| Carbon Mono Oxide |
| Sulphur Dioxide |
| Hydrocarbons |
| Nitrogen Oxide |
| Dew Point |
| Non- Viable Particle Count |
| Viable Particle Count |
| Oxygen Content |
| Nitrogen Purity |
| Pure Steam Generator | Description | Yearly (±1 Month) | HTM 2010, Part 03 |
| pH |
| Conductivity |
| Total Organic Carbon |
| Nitrate |
| Acidity & Alkalinity |
| Total Bacterial Count |
| Bacterial Endotoxin Test |
| Non-Condensable Gas Determination |
| Dryness Fraction Test |
| Super Heat Test |
| Visually Inspector Qualification | Qualification | Yearly (- 1 month) | USP <1790>, ISPE, PDA Guideline |
| Rotation of Visual Inspector | Microbial Count | After every 2 hour | As per SOP |
| IPQA Checks | Product physical parameters | Initial & After every 1 hour | As per BMR & BPR |
| Alert & Action Limit | Chemical & Microbial Tests | After 3rd Phase & Yearly | WHO TRS 961 & 970 |
| Water trend | Chemical & Microbial Tests | Daily Sampling (Trend Preparation monthly) |
| Weekly & Fortnightly (Trend Preparation Quarterly) |
| Monthly &Quarterly (Trend Preparation Yearly) |
| SOP & Manuals | Documentation | After every 3 years or whenever required | As per SOP |
| Stability (Accelerated) | Upto 6 months | Q1A (R2) |
| Stability (Long Term or Intermediate) | After + 1 Year Expiry | As per SOP |
| BMR/BPR | 5 Year from date of manufacturing | As per SOP |
| Log Books | Unlimited | As per SOP |
| Cleaning Validation / Verification | Chemical & Microbial Test | Introduction of New Product & Yearly | Health Canada, PIC/S 006, PDA Technical Report 29, APIC |
| Obsolete/Discontinued Documents | Documentation | After 5 Year | As per SOP |
| Mock Recall | Yearly |
| Self Inspection | Half Yearly |
| Policies | Upto Lifetime |
| Site Master File | Upto Lifetime |
| Validation & Qualification | Upto Lifetime |
| Training & Medical Records | Upto Lifetime |
| Technology Transfer | Upto Lifetime |
| Layout & P & ID Documents | Upto Lifetime |
| Vendor Qualification | Qualification | Upto Lifetime | As per Protocol |
| Change Control procedure | Documentation | Upto Lifetime | As per SOP |
| STP & STS | Upto Lifetime |
| QMS Documents | One Year after Expiry |
| COA | One Year after Expiry |
| Checklist & Formats | One Year after Expiry |
| Media Fill | Simulation of Whole aseptic practices by growth medium | Half Yearly | PICS 007, ISPE GUIDE, ANVISA, Schedule M, FDA_GFI_SEPT 2004, WHO TRS 961, 2011, Annex 6, EU GMP, PDA Technical Report 22 & 28 |
| Container Closure Integrity Test |
| Personnel Qualification | Qualification | 2 Year | As per protocol |
| Internal Audit | Documentation | Yearly | As per SOP |
| Preventive Maintenance | Quarterly |
| Building Maintenance | Quarterly |
| Ground water storage tank | Yearly (±30 days) |
| CIP/UF/RO/EDI/Distribution line Sanitization | Monthly |
| Vent Filter Integrity | Quarterly (±7 days) |
| UV Lamp | After working hours or intensity reduce to 15 w/m2 |
| Riser Filter | After every product changeover or after 10 same batches |
| Pre-Filter | 15 days (±3 days) |
| Fine Filter | Monthly (±3 days) |
| Bore Well Water Testing | Yearly |
| HEPA Filter (Grade A) | 5 Years (±6 months) |
| GPS time verification | Yearly (±1 month) |
| Multi Grade Filter | ΔP across MGF more than 1.0 kg/cm2 |
| Resin of Softener replacement | Hardness more than 4 ppm after regeneration |
| CIP/SIP Validation | Cleaning in Place / Steam in Place | Yearly (In-house) | PDA Technical Report No. 61 PDA Technical Report No. 01 HTM 2010, Part 03 |
| Dry Heat Sterilizer | Heat Penetration Study in Load Chamber | Yearly | HTM 2010, Part 3 USP<1228> PDA Technical Report No. 3 |
| Endotoxin Challenge Test |
| Tunnel Validation | Heat Penetration Study in Load Chamber | Half Yearly | PDA Technical Report No. 3 USP <1228> |
| Process Validation | Evaluation of Critical Process Parameters | Introduction of New Product, Change in Batch Size, Change in Vendor | Process Validation: General Principle & practices, January 2011 EU: Volume4, Annex 15 SUPAC MR-IR-SR |
| Temperature Mapping of Storage areas | Hot point determination | Every 3year | ISPE Guide WHO TRS 961 |
| Temperature Mapping of Equipments | Hot point determination | Yearly for Equipments |
| Door Opening |
| Power Failure |
| PLC Validation | Validation Plan | Initially | PIC/S, GxP Compliance WHO Data management ISPE GAMP 5 21 CFR Part 11 EU GMP Annex 11 |
| Initial Risk Assessment |
| Installation Qualification |
| Operational Qualification |
| Final Risk Assessment |
| Filtration Validation | As per protocol | Initially | PDA Technical Report 22 |
| Stability | As per protocol | Initially | Q1A(R2) |
| Yearly |
| Change in Packing configuration |
| Change in Manufacturing Process |
| Filling & Sealing Machine Validation | Sensor Challenge Test | Yearly | In-house |
| Speed Verification |
| Fill Volume Variation |
| Sealing Quality |
| Cold Chamber | Challenge Test (2-8°C) | After every 15 days | As per SOP |
| Verification of Hot & Cold Point | Daily | As per SOP |
| Sample analysis time | Raw material | 30 days | As per SOP |
| Finished Goods | 30 days |
| Packaging | 15 days |
| Packaging (Sterile) | 30 days |
| Stability | 28 days |
| Reduced testing/Skip testing/Periodic Sampling Plan | Packaging material (Existing Vendor) | Material quality review shall be performed yearly | As per SOP |
| Packaging material (New Vendor) | First 03 batches | As per SOP |
