ACTIVITIES & THEIR FREQUENCIES IN PHARMA

ACTIVITIES	TEST	FREQUENCY	REFERENCE
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

practical pharma GMP activity–frequency guide (typical; finalize per SOP, risk, product, and regulatory expectations).

Per batch / per operation

• Line clearance (start/end, changeover)
• In-process checks (weights, volumes, hardness, friability, pH, etc.)
• Dispensing checks & reconciliation (materials, yields)
• Equipment cleaning (post-use) + cleaning records review
• Batch Manufacturing Record (BMR/BPR) real-time entries + QA review stages
• Filter integrity test (as applicable: before/after use)
• Sterilization cycle review (as applicable)

Daily

• Area housekeeping & cleaning (grade-based)
• Differential pressure / temperature / RH monitoring checks
• Water system key checks (e.g., conductivity/TOC trend, sanitization status—site specific)
• Gowning hygiene checks (where applicable)
• Logbook review (critical utilities/equipment)

Weekly

• Deep cleaning of defined zones (ceilings, vents, drains—per grade)
• Environmental monitoring (some sites: weekly viable/non-viable in controlled areas)
• Pest control checks (trend review, traps—often weekly/biweekly)

Monthly

• Preventive maintenance tasks (selected equipment)
• Calibration due-list review and status reporting
• Utility trending review (HVAC, purified water, compressed air)
• OOS/OOT trend review (QC)
• Deviations/CAPA effectiveness check (open items review)

Quarterly

• Internal audits / self-inspections (schedule-based)
• Supplier performance review (key vendors)
• Training effectiveness checks (GMP refreshers may be quarterly/semiannual)
• Product complaints trending review

Semiannual

• HVAC filter inspections (as applicable)
• Water system sanitization/thermal/chemical cycle verification (site specific)
• Media fill frequency may be semiannual (especially aseptic operations—risk based)

Annual

• Product Quality Review / APR (PQR)
• Annual GMP training / data integrity training refresh
• Annual calibration/verification of key instruments (as per criticality)
• Annual requalification review plan (HVAC, water, cleanrooms—per risk)
• Stability program annual review

2–3 years (risk-based / after major change)

• Full requalification of cleanrooms/HVAC and utilities
• Cleaning validation revalidation triggers review
• Computer system periodic review (CSV)

If you tell me your area (Tablet, Sterile, Ointment, Warehouse, QC lab), I can tailor a frequency matrix exactly to that department.

Tablet, Sterile, Ointment, Warehouse, QC lab

Below is a department-wise GMP activity & frequency matrix (typical). Final frequencies must match your SOPs, risk assessment, product type, and regulatory expectations (e.g., Schedule M/WHO GMP/EU GMP).

Tablet (Solid Oral)

Per batch / shift

• Line clearance (start/changeover/end), label reconciliation
• In-process checks: weight variation, hardness, thickness, friability, disintegration (as applicable)
• Metal detector challenge (start/end + at set intervals), sieve integrity checks
• Equipment cleaning post-use + logbook entry

Daily

• Area cleaning (floors/surfaces), dust extraction checks, DP/T/RH check (if controlled)
• Balance verification (as per SOP)

Weekly

• Deep cleaning (walls, drains, high ledges), pest trap review

Monthly

• Utility trend review (compressed air, HVAC), deviation/CAPA review (open items)
• Preventive maintenance (selected equipment)

Quarterly/Semiannual

• Process/cleaning trend review; re-training (as needed)

Annual

• APR/PQR, annual GMP & data integrity training, critical instrument calibration plan review

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Sterile (Aseptic/Terminal Sterile)

Per batch / session

• Line clearance, sterilization cycle review, filter integrity testing (pre/post use as applicable)
• Aseptic interventions documentation; container closure checks/CCI sampling plan execution

Daily (or each operation day)

• Environmental monitoring (viable/non-viable per grade plan), differential pressure checks
• Disinfection of critical areas; disinfectant rotation per SOP

Weekly

• EM trend review (often weekly), deep cleaning of specified surfaces

Monthly

• HVAC/WFI key trend review (TOC, conductivity, microbial), cleanroom cleaning qualification review (where required)

Semiannual (common expectation, risk-based)

• Media fill/APS (often 2 per year per shift/process, plus after major change)
• Gown qualification revalidation (risk-based)

Annual

• HEPA integrity test, airflow/smoke visualization (frequency may be annual or after changes)
• Sterilizer requalification review, annual aseptic process review

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Ointment/Cream (Non-sterile or Sterile, as applicable)

Per batch

• Line clearance, in-process checks (appearance, viscosity, pH, fill weight)
• Cleaning post-batch; hold time adherence (bulk/filled)

Daily

• Area cleaning; water system checks (if used); temperature/RH where required

Weekly

• Deep cleaning; microbial monitoring (if controlled area)

Monthly

• Trend review: microbial results, cleaning effectiveness, complaints

Annual

• APR/PQR; mixing/filling equipment calibration and PM review

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Warehouse (RM/PM/FG)

Per receipt / dispatch

• Incoming checks (damage, seal status), status labeling, FEFO/expiry control
• Temperature/humidity log review (if controlled)
• Dispensing area line clearance (for RM/PM issue)

Daily

• Housekeeping, segregation checks (quarantine/approved/rejected), pest control checks (as per plan)

Weekly

• Cycle counts (risk-based), pest trend review, cleaning of racks/handling equipment

Monthly

• Stock reconciliation, deviations (temperature excursions) review
• Cold chain performance review (if applicable)

Quarterly/Annual

• Temperature mapping: typically annual for controlled areas, and after major changes
• Supplier transporter qualification review (risk-based)

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QC Lab (Chemical & Microbiology)

Per analysis / daily

• System suitability (HPLC/GC), balance checks, pipette checks (as per SOP)
• Media GPT (as applicable), incubator temp logs, reagent/standard checks

Weekly

• Glassware validation checks (where defined), micro area deep cleaning, EM (if applicable)

Monthly

• Instrument performance checks (e.g., wavelength accuracy, injector precision—per SOP)
• OOS/OOT trend review

Quarterly/Semiannual

• LIMS/CSV periodic checks (if required), reference standard qualification review

Annual

• Instrument calibration schedule execution, stability chamber mapping review, annual training & data integrity assessment