MAIN REGULATORY BODIES AROUND THE WORLD FOR PHARMACEUTICAL PRODUCTS

MAIN REGULATORY BODIES AROUND THE WORLD FOR PHARMACEUTICAL PRODUCTS

Medicines are chemical or natural products used for healing, diagnosing, treating and improving health. These medicines contain API and Excipient. API is the main active drug which provide therapeutic effect and biologically active.  Excipient is non-active ingredient added in formulation along with API in medicine formulation.

Drugs or Medicines are very high importance as these are life saving, health improving, biologically active, provide therapeutic effect.   Drugs or Medicines provide adverse effect or lead to death if they are not manufactured with care and not manufactured in GMP (Good Manufacturing Practices) environment. Due to high risk, every country has its own regulatory body or regulatory authority. These regulatory bodies or regulatory authorities make and enforce rules and regulations and also prepare and issue guidelines for drugs or medicines manufacturing, licensing, registration, marketing, labeling and packaging of pharmaceutical products like tablets, injections, syrups, eye drops, ointment cream, spray, inhalers, liquid and OSD  (oral solid dosage) etc.

List of Main Regulatory Authority around the World

Country	Name of  Regulatory Authority (Full and Short Form of Name)
USA	USFDA – Unites States Food and Drug Administration
UK	MHRA - Medicines and Healthcare Products Regulatory Agency
Australia	TGA - Therapeutic Goods Administration (TGA)
India	CDSCO - Central Drug Standard Control Organization (CDSCO)
Canada	TPD – Therapeutic Product Directorate
	HPFBI – Health Product & Food Branches Inspectorate
Europe	EMA - European Medicines Agency
New Zealand	Medsafe - Medicines and Medical Devices Safety Authority
	ANZTPA – New Zealand Therapeutic Product Authority
China	CFDA - China Food and Drug Administration
South Africa	MCC - Medicines Control Council
Sri Lanka	SPC – State Pharmaceutical Corporation, Ministry of Health
Brazil	ANVISA - Agencia Nacional de Vigiloncia Sanitaria
Vietnam	MOH - Ministry of Health
Malaysia	DCA – Drug Control Authority

Along with these Regulatory Bodies there are some international organizations also to control these pharmaceutical products like WHO (World Health Organization) and ICH (International Conference on Harmonization).

 

Media Filling Process

 Media Filling Process in Pharma Industry

Material issue as per FO (Formulation Order)

Material Verification

Material transfer into critical area (sterile lactose)	Liquid media preparation
Resealing of lactose bags	Check pH
Dispensing and blending with intervention simulation	Sterilize the m/c parts, rubber stoppers , dispensing aids, media garments and bin

m/c parts assembling ( filling) , bin , connection on the day of media filling

Media filling parts assembling and liquid media connection to filling m/c

Vial washing and sterilization

Media Checking for Growth

•  Lactose and liquid media filling stoppering

•  Sealing, crimping of aluminum seal ( sample for sterilize media for GPT, vials , rubber stoppers , compressed air sterility test / viable commit  monitoring)

• Eternal vial washing m/c

• Visual inspection m/c

•  Online leak testing m/c

•   Labeled tray with date / time and other details

• Collect the vials in tray, transfer and handover to micro dept. for incubation through temp. controlled van (truck)

 Preparation of Media

·       Prepare 3% solution of media

·       30gm SCDM (soybean casein digest media) + 1000ml (qs) of wfi (Water For Injection) dissolve in glass carboy.

·       Collect the media sample for pH testing using pH meter and adjust the pH if require.

·       Labeled the media , date of preparation and exp date of media should be 7 days from the date of mfg (Manufacturing Date).

·       Plug the carboy with cotton plug and wrap with breathable cloth sterilize the carboy glass.

·       After sterilization unload the glass carboy in cooling zone and store under UAF on SS table (Stainless Steel Table).

·       Transfer the media carboy to vial filling room through the UAF mounted mobile trolley.

·       End of operation collect the media solution from each carboy and send to micro lab for GPT.

·       Incubate the media in micro lab for 7 days at 20⁰C to 25⁰C followed by 7 days at 30⁰C to 35⁰C.

·       Record the observation in microbiology validation green sheet.

GPT

          Growth Promotion Test, to insure that the liquid media used for the process simulation test is capable of microbial growth promotion.

Lactose Powder

                              Sterilized by gamma radiation method Lactose transfer in critical area

·       Gamma radiation sterilized powder of lactose => qc (quality Control) released => clean with lint free wipe

·       Outer carton and polybag removed in material transfer airlock

·       Pack sanitized and enter into pass box

·       Critical area

·       Lactose bags shall open inside the RABS (restricted access barrier system)

Dispensing Procedure

·       Lactose passes through mesh 36 over the ss-bin using the spoon

·       Load the bin on mixing column

·       Blend for 30 min

·       Unload the bin and transfer it into RABS

·       Remaining quantity also passed by same procedure

·       Quadruplet sampling carried out from 10 location (don’t take out sample only simulate)

·       Simulate pulled sample collection from 3 location (twice) for bulk analysis

·       Transfer the bulk containing lactose for vial filling operation

Assembling Vial Filling m/c Parts

·       Assembled the liquid media filling parts ( peristaltic pump with needles and silicon hose )

·       SS bin containing sterilize lactose

·       Upload it with lifting column

·       SS bin connect to powder hopper chute of vial filling m/c

·       Assembling the pre end post air flushing assembly

·       Insure that vials are flushed with sterile ( filtered ) compressed air during the filling process

·       30/40 ml vial – 50ml volume ( 250mg lactose) filled

·       100ml vial – 10ml volume ( 500mg lactose) filled

·       Minimum vial quantity to be put for incubation in each media fill operation shall not be less than 10,300 vials ( applicable for all pack sizes )

·       Record the collection time of media filled vials on each tray / boxes and affix the label

USE of Sterilize Lactose

·       Flow ability through the hopper and dosing wheel is similar to the product manufacture

·       It does not inhibit the growth of microbes and has growth promotion activity

·       Soluble in media and water

·       Sterilized by gamma radiation

Incubation Period

·       7 days ( bacterial growth ) – 20 to 25⁰C

·       7 days ( viral growth ) – 30 to 35⁰C 

·       Total 14 days incubation.

  

         1.  30/40ml vials 5500 to 6500 vials/hrs., lactose filled using single dosing mechanism      

            2. 100ml vials 2500 to 3500 double dosing wheel mechanism

Post Media-fill Activity

·       Clean and sanitize the equipment (used for media fill activity)

·       The final rinse sample (from product contact part) should be analyses for TOC

·       The TOC in the rinse water sample shall not exceed 500ppb

Vial	Stopper	Seal
30ml	20mm	20mm
40ml	20mm	20mm
100ml	28mm	28mm
Tubular vial	Bromobutyle rubber stopper	Flip off

Media-fill Failure

·       In case of media fill failure respective procedure of OOS ( out of specification) in microbiological analysis , investigation , deviation management shall be followed

·       Characterization of microorganism up to species level shall be carried out to find out the sources of contamination

·       Environmental records for manufacturing and testing area for temp. RH , DP and non-viable air born particle counts

·       Microbiological monitoring, reports of manufacturing and testing area for settling plate air sampling, surface monitoring and personnel monitoring.