Basic pharmacy terms/definations part 3

Empty Capsule Shell Weight & Capsule fill volume / weight capacity according to the density of the powder.

Dimensional Specification:

The following specifications apply to Capsugel hard gelatin capsules.

Weight:

The average capsule weight of an order is estimated by a representative sample average of 100 capsules falling within the limits given bellow:

(values in mg for one capsules)

Size	Target (mg)	Limits (mg)
000	163	150 – 176
00	122	112 – 132
0 el	112	103 – 121
0	96	86 – 105
1	77	69 – 85
2	62	56 – 68
3	49	44 – 54
4	39	36 – 44
5	27	24 - 36

A moisture content of 14% to 14.5% is assumed upper and lower limits are given at the 99.9% confidence level.

In empty hard gelatin capsule production wall thickness is carefully monitored and controlled by the regulation of gelatin solution viscosity. However, since the physical properties of raw gelatin are not constant. Solution density may vary and affect the resultant capsule weight. Therefore the above target weight should not be used as tare weights in capsule filling samples from the actual batch being filled should be taken as tare weights.

Capsule capacity:

The average capsule volume and filled capsule weight capacity for typical powder dose densities is as follows:

Capsule Size	Capsule Volume ML of Water	Capsule weight capacity in mg
		Powder dose density
		0.6 g/cc	0.8 g/cc	1.0 g/cc	1.2 g/cc
000	1.37	822	1096	1370	1644
00	0.95	520	760	950	1140
0 el	0.78	458	624	780	936
0	0.68	408	544	680	816
1	0.50	300	400	500	600
2	0.37	222	296	370	444
3	0.30	180	240	300	360
4	0.21	126	168	210	252
5	0.13	78	104	130	156

The above data are to be considered as approximations since filling product variables and filling machine type can significantly affect the capsule weight capacity.

What is training ? What are the functions of Qualified and key personnel in a Pharmaceutical Industry ? 

 

1.What is training ? Why it is needed ?

Training: Training is a tool/way to know something to increase our knowledge or skill.

Importance of training:

Training helps to provide an opportunity and broad structure for the development of human resources technical and behavioral skills in an organization. It also helps the employees in attaining personal growth.

2.What are the functions of Qualified and key personnel in a Pharmaceutical Industry ?

              I.A qualified person must ensure that each batch has been produced & tested/ checked in accordance with the directives & marketing authorization

           II.A qualified Person musr certify in a register or equivalent document as operations are carried out & before any release that each production batch satisfies under the requirement of GMP

Functions of key personnel in a Pharmaceutical Industry:

              I.To ensure that the production records are evaluated and signed be an authorized person before they are sent to the QC department.

           II.To check the maintenance of his department, premises and equipment.

         III.To ensure that the appropriate validations are done.

        IV.To approve or reject, as sees fit, starting materials, packaging materials. And intermediate, bulk & finished products.

           V.To evaluate batch records.

        VI.To ensure that all necessary testing is carried out

      VII.To approve specifications, sampling instructions, test methods and Quality Control procedures.

   VIII.To approve and monitor any contract analysis.

What are the basic requirements of premises of pharmaceuticals production Area, product & RM Storage Area?

1.What are the basic requirements of premises of pharmaceuticals production Area?  

Premises of Manufacturing Area

1.Dedicated facilities

2.Logical flows of materials and people.

3.Adequacy of working space and orderly and logical positioning of equipment.

4.Interior surfaces smooth, crack-free and easy to clean.

2.What are the basic requirements of premises of pharmaceuticals product & RM Storage Area?  

Premises of RM store Area

1.Storage areas of sufficient capacity

2.Clean, dry and maintained within acceptable temperature limit

3.QC sampling area with GMP standard

4.Segregated areas for rejected recalled and returned materials

5.Separate areas for highly active hazardous narcotics materials

Premises of Manufacturing Area

5.Dedicated facilities

6.Logical flows of materials and people.

7.Adequacy of working space and orderly and logical positioning of equipment.

8.Interior surfaces smooth, crack-free and easy to clean.