Kwality Pharmaceuticals Pvt. Ltd.

TRIAL BATCH SERIAL

Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

Table no. 1NA

First formulation in software
Sr. No Name of Quantity % Total Quantity
ingredient

table INJ – 2 NA
Market sample assay and excipient testing
S. No Description Results S. No Description Results
Avg weight Excipients SLS
Avg fill Excipients starch
DT Excipients Lactose
Dissolution Excipients SSG type 1
Assay

1
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000
Table INJ – 3 (API and Excipient properties)
S. Name of Category Melting Heat Uses Bulk LOD Solubility/ Any other
No material point in sensitivity density Insolubility specification
0
C
1 (Clindamysin) Antibiotic 142.2 - None Clindamycin Freely soluble in Store in
A white or 144.7°C is used to water, in airtight
practically treat a wide dimethylformamide, containers
white variety of and in methyl
alcohol; soluble in
crystalline bacterial
alcohol; practically
powder, infections. insoluble in
odourless or It is an acetone.
has a faint antibiotic
mercaptan- that works
like odour. by stopping
the growth
of bacteria.
This
antibiotic
treats only
bacterial
infections.
2
3
4
5
6

Table no 4

Sieve no 14 16 18 22 25 35 40 44 50 60 80 100 NRS *

Result in %
Table no 5

2
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

Discussion 1

Decision to be taken on following subjects

1. No of trials to be taken ……………. As per Table INJ – 6
2. Composition of each trial for list of excipients
3. Procedure for each trial
4. No of trials required for reason change in the excipient for pH, for Stability, for colour and clarity, for solubility

3
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

Trial table 6, 7& 8 will be repeated for each trial, Trial-1

Table-6 Trial Table with Composition

Table-6.1 Trial No. 1

Date for proposing trial: 13/12/2017 Start time: End time:
Proposed parameters:
Average fill of 427 mg LOD of Capsule shell size 1 size Empty capsule 76 mg
capsule powder shell weight

Avg. wt. of 503 mg LOD of Avg.wt. on dried basis Batch size for 1000
Capsule final trial Capsules
Capsule

Proposed trial no. : Trial 1

S.no Name of ingredients Weight of LOD in % Weight on Remarks
ingredientsin dried basis
gm
1 Clindamycin HCL 325.6 gm 4.4 % 339.9 or
340 gm
2 Lactose 53.5 gm 0.0 53.5 gm
3 Starch 10.20 gm 0.0 10.20 gm
4 Talcum 8.10 gm 0.0 8.10 gm
5 Sodium Starch Glyconate Type A 9.20 gm 0.0 9.20 gm
6
7
8
9 Magnesium Stearate 6 0 6
TOTAL 427 gm

4
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000
Procedure:

1. Dry the starch & Lactose in Tray dryer at 100 0C for 4hrs
2. Take Clindamycin HCL mix with lactose , Sodium Starch Glycolate A and starch for 20 min in Rotacube Mixer.
3. Now Sift the material through 60#.
4. Now mixed material mix ,with talcum and send to capsule filling room.

Calculation : Clindamycin 300 mg Equivalent to 340 mg.

Size of Capsule "1"

Weight of empty capsule per tray – 54.720 gm

Weight of powder in each capsule - 427 mg

Weight of powder per capsule tray -307.440gm/tray

Total weight of empty capsule per tray + Weight of Powder per tray ( 720 ) 54.720 + 307.440 gm =362.16 gm

Molecular weight of Clindamycin HCL = C18H33CLN2O5S,HCL= 461.4

Molecular weight of Clindamycin - 425 ( C18H33CLN2O2S )

Factor =461.4/425x300= 325.6 mg

Water =3.0-- 6.0%

Achieved =4.4

Hence =325.6 + 4.4 % = 340.02 mg

5
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

Announcement Time #10:02:47 AM# ------------------------------

Announcement from : Rohit Singh- 245 [KPL@1-10]
Clindamycin Capsules BP 300 mg
6419/21
C-1274 Trial-1
Disso : HPLC : 109.81% 104.70% 108.16% 109.83% 106.58% 103.77%
Apparatus Basket
Run Time 30 Min.
Limit NLT 80% (Q )
Assay : HPLC : 104.74%
Limit 90% -110%
Analyst : Jarmanjit Singh

Tablet – 7 (Angle of repose):-

Height of Diameter of Angle of repose =tan Angle of repose Flow properties Remarks
powder(h) powder cone (d) x=h/0.5*d

25-30 Excellent
31-35 Good
36-40 Fair-aid not needed
41-45 Passable
46-55 Poor
56-65 Very poor
>65 very, very poor

6
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000
Discussion 2:
On the basis of pH, colour and clarity the decision should be taken to send to lab for stress test, assay, colour and clarity.

Table no. 8

Trial Description Assay Observation Remark

Discussion 3 after the lab report

Trial extract
DATE OF TRIAL:

Trial Number:………………, Procedure Number: ………………….

API PROPERTIES:

7
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000
To check raw material and excipients physical properties like Solubility …. Figure only, Colour and clarity of solution 10% or
whatever …. Figure only, pH …….. Figure only, Melting point of API…… Figure only, Water sensitivity of API ….
Information as document, Heat sensitivity of API ……Information as document, Impurities ……… Figure only, for each raw
material and excipient as per Tablet INJ – 3.

Parameter selected for Capsule: a) Avg Fill -

b) Type of shell used: -

c) Uniformity of powder -

d) Assay of capsule: -

E) PHARMACOPIEASPECIFICATION:

f) Lot size of trial …

Proposed formulation: As per trial number: …………..

S Name of product Quantity overage Total Function of excipient

no calculated quantity
1
2
3

Analytical report results:

8
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000
CONCLUSION: Risk factor, adopting of procedure, In-Process control

1. Risk Factor: at stage of mixing excipients, at stage of mixing API, at stage of filtration, at stage of filing, at
stage of checking ampoules, risk of environment at time of manufacturing and filling.
2. \PROPOSED FLOW SHEET: a) prepared by_______ b) checked by_______

Clindamycin
Generic Name: clindamycin (oral/injection) (klin da MYE sin)
Brand Names: Cleocin HCl, Cleocin Pediatric, Cleocin Phosphate, Cleocin Phosphate ADD-Vantage

 Overview
 Side Effects
 Dosage
 Professional
 Tips
 Interactions
More
 Pregnancy Warnings
 Breastfeeding Warnings

9
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

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What is clindamycin?
Clindamycin is an antibiotic that fights bacteria in the body.
Clindamycin is used to treat serious infections caused by bacteria.
Clindamycin may also be used for purposes not listed in this medication guide.

Think Before You Ink: Health Risks Associated With Tattoos

Important information
Clindamycin can cause diarrhea, which may be severe or lead to serious, life-threatening intestinal
problems. If you have diarrhea that is watery or bloody, stop using this medicine and call
your doctor.
Before using clindamycin, tell your doctor if you have kidney disease, liver disease, an intestinal
disorder such as colitis or Crohn's disease, or a history of asthma, eczema, or allergic skin reaction.
Take clindamycin for the full prescribed length of time. Your symptoms may improve before the
infection is completely cleared. Skipping doses may also increase your risk of further infection that
is resistant to antibiotics. Clindamycin will not treat a viral infection such as the common cold or
flu.

10
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need
to stop using it for a short time.

Before taking this medicine

You should not use this medicine if you are allergic to clindamycin or lincomycin.
To make sure clindamycin is safe for you, tell your doctor if you have ever had:

 colitis, Crohn's disease, or other intestinal disorder;

 eczema, or allergic skin reaction;
 liver disease;
 asthma or a severe allergic reaction to aspirin;
 if you also take erythromycin; or
 if you are allergic to yellow food dye.
It is not known whether clindamycin will harm an unborn baby. Tell your doctor if you are pregnant
or plan to become pregnant during treatment.
Clindamycin can pass into breast milk and may cause side effects in the nursing baby. Tell your
doctor if you are breast-feeding.
Do not give a clindamycin injection to a child without medical advice. The injectable medicine
contains an ingredient that can cause serious side effects or death in very young infants or
premature babies. Do not allow an older child to use this medicine without supervision of an adult.

How should I use clindamycin?

Take clindamycin exactly as prescribed by your doctor. Follow all directions on your prescription
label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Take the capsule with a full glass of water to keep it from irritating your throat.
Measure the oral liquid with the dosing syringe provided, or with a special dose-measuring spoon
or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

11
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

Clindamycin is sometimes given as an injection into a muscle, or injected into a vein through an IV.
You may be shown how to use injections at home. Do not self-inject this medicine if you do not
understand how to give the injection and properly dispose of used needles, IV tubing, and other
items used to inject the medicine.
Use a disposable needle only once. Follow any state or local laws about throwing away used
needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist
where to get one and how to throw it away). Keep this container out of the reach of children and
pets.
To make sure this medicine is not causing harmful effects, you may need frequent medical tests
during treatment.
If you need surgery, tell the surgeon ahead of time that you are using clindamycin.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the
infection is completely cleared. Skipping doses may also increase your risk of further infection that
is resistant to antibiotics. Clindamycin will not treat a viral infection such as the flu or a common
cold.
Store at room temperature away from moisture and heat. Protect the injectable medicine from
high heat.
Do not store the oral liquid in the refrigerator. Throw away any unused oral liquid after 2 weeks.
Dosage Information (comprehensive)

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your
next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

12
 Kwality Pharmaceuticals Pvt. Ltd. TRIAL BATCH SERIAL
Village. Nag Kalan, Majitha Road, Majitha – 143601. NO PAGE NO 1-10
TRIAL BATCH MANUFACTURING RECORD DATE 30/01/2013 Section: Injection

Brand name :- Clindamycin 300 mg Capsule Price per Kg or Gram of API: Revision: 001
Date of application of this format
Correct Generic name: Clindamycin 300 mg Capsule 16-07-2014
Trial BMR No. 1

New product : YES Work order number: Name of the party and his Temperature at the time of
destination country : taken trial
6419/21 Intercontinental

QUANTITY OF EYE DROPTO BE PRODUCT CODE NO PHARMACOPEIAL Packing:

MANUFACTURED AS PER FRIENDS REFERANCE : BP
SOFTWARE
144000

What should I avoid while using clindamycin?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have
diarrhea that is watery or bloody, stop using clindamycin and call your doctor. Do not use anti-
diarrhea medicine unless your doctor tells you to.

Clindamycin side effects

Get emergency medical help if you have any signs of an allergic reaction to clindamycin: (hives,
difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat,
burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and
peeling).
Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts
of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle
aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may
occur several weeks after you began using clindamycin.
Clindamycin can cause diarrhea, which may be severe or lead to serious, life-threatening intestinal
problems. If you have diarrhea that is watery or bloody, stop using clindamycin and call your
doctor.

13