Beberapa hari yang lalu saya mendapatkan file tentang referemsi dan pengetahuan umum di internet. Rangkuman ini sangat lengkap dan berguna bagi kita yang bekerja di industri farmasi. Dengan rangkuman ini dapat dengan cepat diketahui singkatan-singkatan di industri farmasi/CPOB serta mengetahui referensi dari berbagai hal sebagai dasar dalam pembuatan berbagai laporan di industri farmasi.
Penampakan Halaman Pertama seperti ini:
Berikut contoh Reference Guidenya:
| Process/activity | Reference Guideline/method |
| Process validation | PV FDA JAN-2011 EMA 2012 Including(ICH Q8, Q10) |
| Blend Uniformity & Content Uniformity (stratified sampling) | ISPE (December 2014) ASTME 2709/E2810 USP Chapter No: 905 |
| Friability | USP chapter 1216 |
| Disintegration | USP chapter 709 |
| Hold Time Study | WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty- ninth report. Geneva: World Health Organization; 2015: Annex 3 (WHO Technical Report Series, No. 992). |
| Dissolution | USP chapter 711 |
| Cleaning Validation | ICH Q3 C (R5) Health Canada –Draft Cleaning validation guideline (GUI0028) FDA guideline to inspections Validation of cleaning Process.(1993) PICS., APIC HSA JAN 2013 WHO Technical series 937, 2006 Annex 4, Appendix 3 |
| AQL (Critical-0.010% & non-Critical-0.65%) | ISO 2859-1 General inspection level-iii British standard BS. 6001:1999-1 Level III |
| PSD Test for QC | GTP no. – GTP/USP/016 |
| BD Test for QC | GTP no. – GTP/USP/017,/028 |
| Stability | ICH- Q1A R2 to Q1E |
| MHRA/USFDA- PQR/APQR | EudraLex Volume 4 Health Science Authorities (HSA) PICS |
| Transport Route Profiling & Qualification | WHO stand-TRS 961 annex 9 Requalification: Change in routeChange in transport vendorChange in transport conditionsEvery five years (risk based suggestion) |
| Quality Risk Management | ICH Q9 WHO Guidelines-TRS-981 ,Annexure-II |
Untuk singkatan-singkatan dalam farmasi sebagai berikut ini:
ISPE :International society of Pharmaceutical Engineering
ASTME :American standards of testing and material
ICH :international council on harmonization
EMA :European medicinal agency
HSA :Health science Authority
SAP :System Application And Product in Data Processing(SAP R/3 4.7 Enterprise Edition is a software application used by companies around the world to run their businesses.)
SCM: : System Chain Management
RMG : Rapid Mixer Granulator
SMG : Saizoner mixer granulator
RLAF : Reverse Laminar Air Flow
LAF : Laminar Air Flow
VTS : Vacuum transfer system
HVAC : Heating, Ventilation and Air Conditioning
AHU : Air Handling Unit
HEPA : High Efficiency Particulate Air filter.
ULPA : Ultra-Low Penetration Air
VMP : Validation Master Plan
LOAEL : Lowest Observed Adverse Effect Level
NOEL : No Observable Effect Level
PDE : Permitted Daily Exposure
ADI : Acceptable Daily Intake
MAR : Maximum allowable residue
MACO : Maximum Allowable Carryover
PIC/S : Pharmaceutical Inspection Co-Operation Scheme
CTD : Common Technical Document
MSDS : Material Safety Data Sheet
BOPP : Biaxial Oriented Ploy Propylene
MPD : Master packing documents
CPV : Continues Process Validation
CPP : Critical Process Parameters
CQA : Critical Quality Attribute.
SUPAC : Scale –Up and Post approval changes
SUPAC IR : Immediate release
SUPAC MR : Modified release
Certification & Standards of ISO:-
ISO 9001:2015 – Quality Management System
ISO 14001: 2015 – Environment Management System:
ISO 45001:2018 – Occupational Health & Safety Management System
( International Council on Harmonization)
1989-WHO Conference of Drug Regulatory Authorities produced action plans for regulation of medical research
(US, JAPAN, Switzerland, Canada, Europe)
| Q1 Stability | Q7 Good manufacturing practice (API) |
| Q2 Analytical method validation | Q8 Pharmaceutical development |
| Q3 Impurities | Q9 QRM |
| Q4 Recommendation of pharmacopoeia | Q 10 Pharmaceutical Quality system |
| Q5 Biotechnological products | Q11 Development and manufacture of drug substances |
| Q6 specification test procedure and acceptance criateria | Q12 Life cycle management |
| Q13 Continual Manufacturing |
TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C–DRUGS: GENERAL
Part-11 – Electronic records & signature Part-58 – Good laboratory practice (GLP) Part-210 -cGMP General
Part-211 -cGMP for finished product
1) 211.192 Batch Review (Investigations)
- 211.22(d) Responsibilities of QCU
- 211.110(a) In-Process Sampling/Testing
- 211.100(b) Adherence to Production Procedures
- 211.100(a) Production Procedures (Validation)
- 211.160(b) Laboratory Controls
- 211.165(a) Testing and Release
- 211.188 Batch Record Review
- 211.25(a) Personnel Qualifications
- 211.67(a) Equipment Cleaning and Maintenance 11) 211.180 (e) APR
12)
Requirements of APRs are found in 21 CFR 211.180 (e) and include:
- procedure
- Review Written of Every batch (or Representative) to determine the need for changes in specification or manufacturing or control procedures
- Review of complaints
- Review of recalls
- Review of returned and salvaged products
- Review of investigations
21 CFR Part 211
| Subpart | Clause |
| A. General provisions | – |
| B. Personnel & Qualifications | 211.25 Personnel Qualifications. 211.28 Personnel responsibilities. |
| C. Building & facilities | 211.42 Design and construction features. 211.44 Lighting. 211.46 Ventilation, air filtration, air heating and cooling. 211.48 Plumbing. 211.50 Sewage and refuse. 211.52 Washing and toilet facilities. 211.56 Sanitation. 211.58 Maintenance |
| D. Equipment | 211.63 Equipment design, size, and location. 211.65 Equipment construction. 211.67 Equipment cleaning and maintenance. |
| E. Drug product containers & closures | 211.80 General requirements. 211.82 Receipt and storage of untested components, drug product containers, and closures. 211.84 Testing and approval or rejection of components, drug product containers, and closures. Use of approved components, drug product containers, and closures.Retesting of approved components, drug product containers and closures. 211.89 Rejected components, drug product containers, and closures. 211.94 Drug product containers and closures. |
| F. Production & process control | Written procedures; deviations.Charge-in of components. 211.103 Calculation of yield. 211.105 Equipment identification. Sampling and testing of in-process materials and drug products.Time limitations on production. 211.113 Control of microbiological contamination. 211.115 Reprocessing. |
| G. Packaging & labeling control | 211.125 Labeling issuance. 211.130 Packaging and labeling operations. 211.134 Drug product inspection. 211.137 Expiration dating. |
| H. Holding and Distribution | 211.142 Warehousing procedures. 211.150 Distribution procedures. |
| I. Laboratory controls | Testing and release for distribution.Stability testing. 211.170 Reserve samples. |
| J. Records & Reports | 211.180 General requirements. 211.182 Equipment cleaning and use log. 211.184 Component, drug product container, closure, and labeling records. 211.186 Master production and control records. 211.188 Batch production and control records. 211.192 Production record review. 211.194 Laboratory records. 211.196 Distribution records. |
| K. Returns & Salvaged Drug products | 211.204 Returned drug products. 211.208 Drug product salvaging. |
CALIBRATION
| Equipment | Step Of Calibration |
| Analytical Balance (Sartorius) | Accuracy Test – 120.0000gm Capacity as per united state pharmacopeia. Theoretical weight A (gm.)/standard weight/tolerance 0.10%/observation. 10.0/20.0/50.0/100.0gm. Repeatability test:- Theoretical weight 50.0gm/put 10 times once location/observation SD-……………, D(least count)-0.0001gm/ repeatability :- 2XSD / (Theoretical weight)X100 Note: if the standard deviation obtained is smaller than 0.41d, where d is the scale interval ( i.e. least count), replace the standard deviation with 0.41d. in this calculate repeatability using following equation : 2X0.41d/ (Theoretical weight)X100 |
| Friability (Electro lab) | 04 Min./….Actual observation/ Tolerance limit 234-246Sec.25 Revolution-3times/ Actual observation/Tolerance limit 24- 26Rev./min. |
| DT (Electro lab) | Temp. of water bath/Actual observation / Tolerance limit 37-39CTemp. in beaker/ Actual observation L&R/ Tolerance limit 37±2CNo. of strokes/min./4times Actual observation L&R/ Limit 29-32 cycle./min.Stroke heights/ Actual observation L&R/ Tolerance limit 55 ±2mm.Baskets lower most position/ Actual observation L&R/ 25 mm.Sieve Integrity/ Actual observation L&R/ 2.0mm ±0.2mm |
| Hardness | |
| Moisture Analysis (Mettler Toledo) | 1. 5.0 gm. talc powder/weight of water 0.200gm/%Moisture content /Acceptance Criteria=100 ±2% |
Untuk selengkapnya rangkuman dalam bentuk PDF dapat di download disini http://bit.ly/farmasiindustridotcom2
Semoga Bermanfaat
Salam
M. Fithrul Mubarok, M. Farm.,Apt
