Audits & compliance management
- GAP analysis for old and new facility.
- GMP & regulatory audits compliance support in accordance with USFDA, PIC/s, EU, MHRA, TGA, WHO etc.
- Good laboratory practices (GLP) including support for NABL, local FDA & USFDA registration and certification.
- Good distribution practices
- Good documentation practices
- Assessment for data integrity breach and its mitigation
Documentation & Validation Support
- We support in drafting, review and documentation of:
- Quality manual
- Site master file
- Validation master plan
- Specifications
- Standard operating procedures (SOP).
- Quality management systems
- Validation & Qualification
- Master formula records (MFR), batch manufacturing records (BMR) & batch packing records (BPR).
- Risk assessment modules for impurities and case studies.
Training- GMP & Regulatory
- We conduct customized trainings on the below mentioned concepts:
- Good manufacturing practices (GMP)
- Good laboratory practices (GLP)
- Good documentation practices (GDP)
- Good warehousing & distribution practices
- Qualification & Validation
- Auditing & Compliance management.
- Pilot plants & technology transfer
- Regulatory guidelines: EU / USFDA / ICH / Pic/s/ WHOGMP.
- Data integrity.
- Risk analysis.
Training- GMP & Regulatory
We conduct customized trainings on the below mentioned concepts;
- Good manufacturing practices (GMP)
- Good laboratory practices (GLP)
- Good documentation practices (GDP)
- Good warehousing & distribution practices
- Qualification & Validation
- Auditing & Compliance management.
- Pilot plants & technology transfer
- Regulatory guidelines: EU / USFDA / ICH / Pic/s/ WHOGMP.
- Data integrity.
- Risk analysis.
Audits & compliance management
- GAP analysis for old and new facility.
- GMP & regulatory audits compliance EU, MHRA, TGA, WHO etc.
- Good laboratory practices (GLP) including support for NABL, local FDA & USFDA registration and certification.
- Good distribution practices
- Good documentation practices
- Assessment for data integrity breach and its mitigation
- GAP analysis for old and new facility.
- GMP & regulatory audits compliance support in accordance with USFDA, PIC/s, EU, MHRA, TGA, WHO etc.
- Good laboratory practices (GLP) including support for NABL, local FDA & USFDA registration and certification.
- Good distribution practices
- Good documentation practices
- Assessment for data integrity breach and its mitigation
Documentation & Validation Support
- We support in drafting, reviewing, and documentation of:
- Quality manual
- Site master file
- Validation master plan
- Specifications
- Standard operating procedures (SOP).
- Quality management systems
- Validation & Qualification,
- Master formula records (MFR), batch manufacturing records (BMR) & batch packing records (BPR).
- Risk assessment modules for impurities and case studies.
Documentation & Validation Support
We support in drafting, reviewing, and
documentation of:
- Quality manual
- Site master file
- Validation master plan
- Specifications
- Standard operating procedures (SOP).
- Quality management systems
- Validation & Qualification,
- Master formula records (MFR), batch manufacturing records (BMR) & batch packing records (BPR).
- Risk assessment modules for impurities and case studies.
Training- GMP & Regulatory
- We conduct customized trainings on the below mentioned concepts:
- Good manufacturing practices (GMP)
- Good laboratory practices (GLP)
- Good documentation practices (GDP)
- Good warehousing & distribution practices
- Qualification & Validation
- Auditing & Compliance management.
- Pilot plants & technology transfer
- Regulatory guidelines: EU / USFDA / ICH / Pic/s/ WHOGMP.
- Data integrity.
- Risk analysis.
Training- GMP & Regulatory
We conduct customized trainings on the below mentioned concepts;
- Good manufacturing practices (GMP)
- Good laboratory practices (GLP)
- Good documentation practices (GDP)
- Good warehousing & distribution practices
- Qualification & Validation
- Auditing & Compliance management.
- Pilot plants & technology transfer
- Regulatory guidelines: EU / USFDA / ICH / Pic/s/ WHOGMP.
- Data integrity.
- Risk analysis.