PRODUCT |
Oral
Rehydration Salts |
LOCATION |
PharmaGuide
Limited (ORS Section) |
BATCH
SIZE |
1000
Sachets |
DOSAGE
FORM |
Powder
(Sachet) |
PROTOCOL
NUMBER |
|
PRODUCT
CODE |
|
SHELF
LIFE |
24
Months |
DEPARTMENT |
NAME |
SIGNATURE |
DATE |
QA Executive |
|
|
|
DEPARTMENT |
NAME |
SIGNATURE |
DATE |
QA Manager |
|
|
|
DEPARTMENT |
NAME |
SIGNATURE |
DATE |
Pharmacist
In-Charge |
|
|
|
- Introduction
- Objective
- Label claim
- Scope
- Responsibilities
- Reference documents
- Manufacturing formula
- Process flow chart
- Rationale for selection of critical steps and its process parameters for validation
- List of equipment's and status
- Validation procedure
- Sampling procedure at different stage
- Acceptance criteria for critical in-process controls and sampling plan
- Prerequisites of process validation
- Yield details
- Process validation report
- Deviation
- Revalidation
- Sodium Chloride BP 2.6 gm.,
- Glucose, anhydrous 13.5 gm.,
- Potassium Chloride BP 1.5 gm.,
- Trisodium Citrate Dihydrate BP 2.9 gm.
Item
code |
Item |
RM
Specification No. # |
Quantity
/ Sachet (gm.) |
Quantity
/ Batch (Kg) |
Function |
|
Glucose Anhydrous
|
|
13.500 |
13.500 |
Active ingredient |
|
Trisodium citrate, Dihydrate
|
|
2.900 |
2.900 |
Active ingredient |
|
Potassium Chloride
|
|
1.500 |
1.500 |
Active ingredient |
|
Sodium Chloride |
|
2.600 |
2.600 |
Active ingredient |
- This step involves mixing of sifted raw material. The purpose of blending is to get a uniform distribution of Sodium Chloride BP 2.6 gm., Glucose anhydrous 13.5 gm., Potassium Chloride BP 1.5 gm., Trisodium Citrate Dihydrate BP 2.9 gm. to get good flow and anti-adhesion property of the blend.
- Mixing speed and time are critical variables in this process. Since speed of the blender is constant, time required for proper mixing shall be determined. Mixing time is critical as less blending will result in non-uniform distribution of drug and poor flow whereas more blending will result in de-mixing leading to non-uniform distribution of drug.
- Proper blending shall be established b checking content uniformity of drug at all the time intervals mentioned in protocol.
- In addition to this following tests shall be carried out for information purpose. This shall be carried out on final time interval samples only.
- Assay
- LOD
- This step involves filling of blended material fill into sachets as per specifications. Speed of machine is major variable. Following physical parameters are to be checked to establish the above mentioned variables at regular intervals.
- Appearance of sachets
- Physical Appearance
- Identification
- pH
- Loss on drying
- Individual weight variation
- Sealing of sachets
- Leak test
- Batch coding details
- Assay
S.
No. |
Equipment
Name |
1 |
Sifter |
2 |
Double Cone Blender |
3 |
Form Fill Seal Machine |
4 |
Printing machine |
- Three batches of 1000 Sachets to be manufactured as described in the Batch Manufacturing Record.
- Current version of standard operating procedures to be followed
- Record the yield after Blending, filling, Inspection and Packing.
Sr.
No |
Parameter |
Standard |
Number
of Sachets to be taken for testing |
1 |
Sachet Fill
Weight |
20.5 mg ± 5 % (19.50 gm. to 21.5 gm.) |
20 Sachets |
2 |
Batch
Coding Details |
Batch No., Mfg. Date, Exp. date |
20 Sachets |
3 |
Sachet
sealing |
Should be proper without leakage |
20 Sachets |
4 |
Leak test |
Should not leak |
5 Sachets |
Stage |
Process
variables |
Time |
Tests
to be performed |
Approximate
sample size |
Acceptance
criteria |
Responsibility |
Blending |
Blending time |
25 & 30 minutes |
assay |
3x3 samples each between 20.5±1
gm. |
100 ± 10 % RSD NMT 5.0% |
Production/QA / QC |
Sachet filling machine |
Speed of the machine
|
Batch start |
Avg. wt., flow of powder, pH,
Clarity, Leak test, Sealing of sachets, appearance, uniformity of weight and
assay |
25 Sachets |
As per specification |
Production / QA/QC
|
Batch middle |
25 Sachets |
|||||
Batch end
|
25 Sachets |
- The batches shall be manufactured as per Batch Manufacturing Record.
- The equipment's utilized for manufacturing and processing of these batches shall be as per list of Equipment's.
- The raw material used for manufacturing shall be from approved vendors and shall be released by Quality control.
- The critical process parameters of the process shall be evaluated with respect to quality attributes of the products.
- Sampling for in-process control samples shall be carried as per established sampling procedure and plan.
- Critical in-process control shall be evaluated with respect to the laid down specification.
- Finished drug product of these batches shall be analyzed as per laid down test procedures and comply with respect to the predetermined specifications.
- Change of formulation procedures or quality of pharmaceutical ingredients.
- Change of equipment, addition of new equipment, major breakdowns / maintenance that affect the performance of equipment's.
- Major changes of process parameters.
- Change in facilities.
- On appearance of negative quality trends.
- On appearance of new findings based on current knowledge.
- Batch size change.