Referensi dan Pengetahuan Umum Industri Farmasi

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:

General Knowledge Pharmacy

Berikut contoh Reference Guidenya:

Process/activityReference Guideline/method
Process validationPV 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
FriabilityUSP chapter 1216
DisintegrationUSP chapter 709
Hold Time StudyWHO Expert Committee on Specifications for Pharmaceutical Preparations: forty- ninth report. Geneva: World Health Organization; 2015: Annex 3 (WHO Technical Report Series, No. 992).
DissolutionUSP chapter 711
Cleaning ValidationICH 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 QCGTP no. – GTP/USP/016
BD Test for QCGTP no. – GTP/USP/017,/028
StabilityICH- Q1A R2 to Q1E
MHRA/USFDA- PQR/APQREudraLex Volume 4 Health Science Authorities (HSA) PICS
Transport Route Profiling & QualificationWHO stand-TRS 961 annex 9 Requalification:  Change in routeChange in transport vendorChange in transport conditionsEvery five years (risk based suggestion)
Quality Risk ManagementICH Q9 WHO Guidelines-TRS-981 ,Annexure-II
Reference Guide Farmasi

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 StabilityQ7 Good manufacturing practice (API)
Q2 Analytical method validationQ8 Pharmaceutical development
Q3 ImpuritiesQ9 QRM
Q4 Recommendation of pharmacopoeiaQ 10 Pharmaceutical Quality system
Q5 Biotechnological productsQ11 Development and manufacture of drug substances
Q6 specification test procedure and acceptance criateriaQ12 Life cycle management
Q13 Continual Manufacturing 




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


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

A.  General provisions
B. Personnel & Qualifications211.25 Personnel Qualifications. 211.28 Personnel responsibilities.
C.  Building & facilities211.42 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. Equipment211.63 Equipment design, size, and location. 211.65 Equipment construction. 211.67 Equipment cleaning and maintenance.
E. Drug product containers & closures211.80 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 controlWritten 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 control211.125 Labeling issuance. 211.130 Packaging and labeling operations. 211.134 Drug product inspection. 211.137 Expiration dating.
H. Holding and Distribution211.142 Warehousing procedures. 211.150 Distribution procedures.
I.    Laboratory controlsTesting and release for distribution.Stability testing. 211.170 Reserve samples.
J.   Records & Reports211.180 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 products211.204 Returned drug products. 211.208 Drug product salvaging.


EquipmentStep 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
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

Semoga Bermanfaat


M. Fithrul Mubarok, M. Farm.,Apt
M. Fithrul Mubarok, M.Farm.,Apt adalah Blogger Professional Farmasi Industri pertama di Indonesia, pendiri dan pengarang dari FARMASIINDUSTRI.COM sebuah blog farmasi industri satu-satunya di Indonesia. Anda dapat berlangganan (subscribe) dan menfollow blog ini untuk mendapatkan artikel terkait farmasi industri. Email: [email protected] WhatsApp/WA: 0856 4341 6332

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