Pharmaceutical Guidance Complete Pharma Solution
- Q7 GMP Guidance for Active Pharmaceutical Ingredients
- STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2)
- STABILITY TESTING OF NEW DRUG SUBSTANCES Q1A(R2)
- Cleaning Validation as per APIC Guideline
- ANDA Submissions — Content and CTD Format (USFDA)
- DGFT guidelines for Barcoding as per GS1 Standards Pharmaceuticals
- US FDA Data Integrity
- Process Validation Guidances: FDA and Global
- Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification
- Good storage practices for pharmaceuticals as per regulatory Guideline
- stability tests for pharmaceutical products
- Phases of clinical trials
- Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA
- Sampling of starting and packaging materials: Glycerol as per EU GMP
- Pharmacovigilance
- EU and US GMP/GDP: Similarities and Differences
- USFDA Generic Drugs: Questions & Answers
- USFDA Foreign Priorities, Inspections and Compliance
- DATA INTEGRITY: ALCOA AND ALCOA PLUS
- Data Integrity: TGA Expectations
- CLINICAL TRAILS
- Definitions and Glossary as per TRS 986 Annex 2
- Drug stability in Pharmaceutical products
- General Terminology used for good Hand hygiene practices as per USFDA
- PHARMACOVIGILANCE PLAN AS PER ICH
- International Organization for Standardization
- LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION
- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL
- Manufacturing Process Development as per ICH -Q11
- Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
- Pass Box for Clean room and it validaton
- Reynolds number and its importance in water system
- Non-sterile process validation as per WHO Technical Report Series, No. 937
- Validation of computerized systems as per WHO Technical Report Series, No. 937
- Analytical method validation as per WHO Technical Report Series, No. 937
- Cleaning validation protocols and reports as per WHO Technical Report Series, No. 937
- Qualification as per WHO Technical Report Series, No. 937
- Validation as per WHO Technical Report Series, No. 937
- Stability Testing of New Drug Products ( Q1A(R2))
- GLOSSARY AS PER STABILITY TESTING ICH GUIDELINE (Q1A(R2))
- Stability Testing of New Drug Substances (ICH Q1A(R2))
- VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY
- VALIDATION OF ANALYTICAL PROCEDURES (DEFINITIONS AND METHODOLOGY)
- GLOSSARY – Validation of Analytical Procedures
- VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS AS PER USP
- ANALYTICAL INSTRUMENT QUALIFICATION
- Analytical Instrument Categories
- USFDA Warning Letters 2016 (API)
- USFDA WARNING LETTER 2016 (Finished Pharmaceuticals)
- USFDA WARNING LETTER 2014 (Finished Pharmaceuticals)