Multilocational details:

Location
Name & Address
Telephone No.
Fax No.
Contact Person
Designation
Email Id
Website
Head Office
ACG Associated Capsules Pvt. Ltd., 131, Kandivli Industrial Estate, Kandivli-West, Mumbai-400067, Maharashtra, India.
+91 22 30700118
+91 22 28682514 / 3258 / 6152
Ms. Patricia Shetty
General Manager - Global Head Plant QA & QC
regulatory.acpl@acg-world.com
http://acg-associatedcapsules.com
Kandivli
ACG Associated Capsules Pvt. Ltd., 130-A & 131, Kandivli Industrial Estate, Kandivli West, Mumbai, 400067,India.
+91 22 30700118
+91 22 28682514 / 6152
Mr. Paschal Vaz
Senior Manager - Quality Assurance
quality.acpl@acg-world.com
http://acg-associatedcapsules.com
Dahanu
ACG Associated Capsules Pvt. Ltd., Ashagadh, Dahanu Road, Dist. Thane - 401602, Maharashtra, India.
+91 02528-304100
+91 2528 260173
Mr. Shaikh Chand
Deputy General Manager - Quality Assurance
quality.acpl@acg-world.com
http://acg-associatedcapsules.com
Shirwal
ACG Associated Capsules Pvt. Ltd., Gat No. - 322,323, Shindewadi, Post. Shirwal, Tal. Khandala, Dist. Satara, Maharashtra, India.
+91 2169 305100 / 305105
+91 2169 305141
Mr. Nanu Paste
Sr. Manager - Quality Assurance
quality.acpl@acg-world.com
http://acg-associatedcapsules.com
ACG Lukaps
ACG Lukaps d.o.o. Frankopanska 79, 42230 Ludbreg, Croatia
+385(42)660118 /+385(98)435127
+385 (42) 660 130
Ms. Andreja Makar
Quality Manager
quality.acpl@acg-world.com
http://www.acg-associatedcapsules.com
Pithampur
ACG Associated Capsules Pvt.Ltd. Plot.No.M29-44,Pharma Zone,Special Economic Zone (SEZ) Phase II,Pithampur,Dist.Dhar, Madhya Pradesh- 454775,India
+91 7292-296740
+91 7292-296740
Mr. Yogesh Mahanubhav
Manager - Quality Assurance
quality.acpl@acg-world.com
http://acg-associatedcapsules.com

Locations

The site is located in a pollution free environment away from potential sources of dust; smoke foul odours and other types of contamination. The manufacturing facility is designed, constructed and maintained to facilitate the manufacturing of hard capsule shells under hygienic conditions. It conforms to the conditions laid down in the Factories Act 1948.

Define batch?

A specific quantity of material produced in a series of processes and expected to be homogeneous within specified limits.

What is batch size?

Minimum: 10 lacs, Maximum: 100 lacs for Domestic & Rest of the World (ROW).

Minimum: 1 million, Maximum: 10 millions for USA & Europe.

Define batch numbering system?

A typical batch number consists of 10 digits, where first 4 digits indicate the manufacturing location while the remaining 6 digits are system generated (SAP) serial numbers incremented by 1 for next batch.

Ex. 1100000278

1100  -   Dahanu location

1110  -   Kandivali location

1120  -   Shirwal location

1150  -   Pithampur location

4100  -   ACG Lukaps location

 

Training Program

Personnel suitably qualified through education, experience and training are engaged in the manufacturing, processing, packaging, distribution and quality assessment of empty capsules.

 

All new employees are put through an induction program of appropriate duration depending upon their grade, position and nature of work. Departmental orientation is provided by the HOD and section in charge.

 

Training on GMP, hygiene, sanitation and SOPs is conducted for all employees whose work impacts quality of the product. In addition personnel are counselled and trained on safety practices, fire fighting and first aid.

 

Training needs of management and supervisory personnel are identified by the HODs based on qualifications, experience and nature of responsibilities. Management personnel are also evaluated annually for performance and any evident training needs identified. Training needs for each category of workmen and staff are identified by HODs as per the nature of work carried out. These are recorded in the training need identification form.

 

A training calendar for internal and external training is drawn to incorporate training for all identified needs and training is provided. Hands on experience is given where necessary. Evaluation is done through objective test or on the job observation and this forms the basis for identification of retraining needs. Training details are recorded in the individuals training card which is maintained by HR department in the employees personal file.

Cleaning & Sanitation

A written housekeeping program is set up, assigning responsibility for sanitation. It outlines the cleaning schedules, methods, equipment and materials to be used in cleaning. Only approved cleaning and sanitizing agents are used.

 

The entire factory has been grouped into following categories:

 

  • Critical areas: Mucilage preparation, Hard Capsule Machines & Printing
  •  

  • Important areas: General stores, Final Quality Control Dept., Finished goods store, Work In Progress site, Production corridors and immediate surrounding areas, staircases, laboratory etc.
  •  

  • Service Areas: Non - production corridors, offices, canteens etc.
  •  

  • Surrounding: Compounds, Utilities etc.
  •  

  • Toilets

 

Cleaning involves a general cleaning for all non-critical areas & specialized cleaning for critical areas.

 

General cleaning for non-critical areas are done by using wet mopping with disinfectant solution such as solution Phenyl for general cleaning & Sodium Hypochlorite (2%) in change room.

 

Specialized cleaning for critical areas are done by using mopping with disinfectant solution such as Virosil, Polysan, Protasan, Sumabac, Sodium Hypochlorite.

 

Compositions are provided below:

 

  • Virosil - Hydrogen Peroxide stabilized with Silver ions.
  •  

  • Polysan - Iodophor containing tamed Iodine.
  •  

  • Protasan - Fatty alcoholethoxylate, Quaternary Ammonium compounds, Benzyl - C12 - 16 - Alkyldimethyl Chlorides, Editic acid, Betain.
  •  

  • Sumabac - Alkyldimethylbenzyl ammonium chloride, Alkylalcohol Ethoxylate, Sodium carbonate.

Pest control program

A Pest Control Program encompasses the entire facility and premises on a regular basis to prevent any insect or rodent infestation.

 

Pest control is done to keep the factory free from pests, rodents and insects. Quotations are invited from various pest control agencies and they are short listed on the basis of their performance and experience. A contract is signed with the agency to undertake pest control as per technical agreement.

 

The effectiveness of pest control is monitored fortnightly. In case of ineffectiveness, the agency is called for investigation of cause and corrective action / measures are implemented.

 

Flycatchers are installed in all critical areas. Cleaning of insectocutors is done once 15 days.

Preventive maintenance program

The maintenance department in conjunction with the user departments is responsible for maintenance of production and testing equipment. Preventive maintenance schedules are drawn for hard capsule manufacturing machine and accessories, gelatin room equipment and capsule printing machines based on their impact on equipment continuity and product quality. These are implemented and monitored.

Validation policy

Process Validation is defined as the process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.

Before process validation can begin, the facilities, equipment, and utilities that will be employed for the process validation activities must themselves be qualified.

Analytical testing methods are validated. Staff taking part in the validation work are appropriately trained.

Stability program

We perform stability study at following condition as per ICH guidelines and conducted on 3 batches per year.

  • Long term stability study: Recommended storage condition of Hard Capsules Shells, Room temperature between 15°C to 30°C and 40% to 65% RH.
  • Short term stability study: 30°C ± 2°C and 65% RH ± 5 %.

Who has responsibility for releasing raw materials, packaging materials, intermediates, finished goods and what is the routine procedure for these activities(e.g.ID test etc.)?

Raw materials, packaging materials, intermediates & finished goods are tested by QC chemist & approved by Head QA in SAP. Test data is entered into SAP. QA responsible person reviews the data & BMR & releases the materials by giving usage decision in SAP.

Is release process via a validated computer system?

Yes validation report no VR/PQ/SAP/01/01 dated 28/1/12.

Describe customer complaint handling?

Customer complaints are received by sales team and recorded in the SAP system from where they are forwarded to QA. Complaint is investigated, evaluated and a corrective action is identified. Customer is informed regarding the outcome and corrective action initiated to prevent reoccurrence.

Change control program

Identify area of Improvement (Seek Approval)

Authorize Trials (Release trial approval )

Conduct Trials as applicable and Validate

Inform customer through formal change control for significant changes which may affect product quality

Implement Change

Monitor & Review changes implemented

Handling of nonconforming products

Nonconforming raw material, packaging material, in process material and finished product are identified, documented and segregated to prevent their inadvertent use.

Nonconforming material is disposed off by one of the following ways as appropriate and concern functions are notified

a) Rework to meet the specified requirements

b) Accept with or without rework by concession

c) Re-grade

d) Scrap or reject

Non conforming products are isolated physically as well as by computers

Handling of out of specification

In the event that a result of a test does not conform to specifications, when performed for the first time, describe what action is taken.

1) Immediate supervisor is informed.

2) OOS investigation starts as per OOS SOP and protocol.

3) Retests are performed if OOS result is invalidated by evidence. Retest is performed on the same sample.

4) Production review done if no assignative cause is found.

5) Verdict.

Handling of deviation

1) Planned deviations involving change in process or systems are handled through Change Control and monitored.

2) In case of unplanned deviation (e.g. Power fluctuations in Mfg. Area) the person who observes the deviation informs the observation immediately to his Supervisor. Supervisor inform HOD-QA and raise the deviation form. HOD- QA or his representative visits the site of deviation and record their observations. Cause of deviation is investigated and actions are planned for correction of the same. Completions of correction activities are monitored.

What percentage of your business is for the pharmaceutical & nutraceuticals?

80% for pharmaceutical and 20% for nutraceuticals.

Retention period for preserved samples & batch records?

6 years.

Are you division or subsidiary of another company?

Yes, we are division of ACG Worldwide.

Production capacity utilization

90-95%.

Year of Establishment

1961 - Kandivli
1983 - Dahanu
1997 - Shirwal
1981 - ACG Lukaps

2013 - Pithampur

 

Installed capacity

Hard Gelatin Capsule Shells

Dahanu - 20.31 billion per annum

Kandivli - 16.85 billion per annum

Shirwal - 19.97 billion per annum

Pithampur -  23.64 billion per annum

ACG Lukaps - 8.43 billion per annum

Total - 89.22 billion per annum

 

Cellulose Capsule Shells

Dahanu - 2.23 billion per annum

Pithampur - 6.03 billion per annum

Total - 8.27 per annum

Last date of FDA inspection by local authority

Dahanu –  17 August 2016

Shirwal – 16 November 2016

Kandivli – 31 January 2017

ACG Lukaps – 11 September 2014

Pithampur - 07 July 2015

 

Commercial Details:

Location
Excise Duty ECC No.
Excise Range
Excise Division
Excise Collectorate
VAT No./ TIN No. / LST No.
TAN No.
CST No.
MICR CODE
PAN No./ TCS FLAG
TDS FLAG No.
Service Tax No.
Sales Tax (BST)
Excise Tariff No. 1
Excise Tariff No. 2
Import Export Code Number
Factory Registration No.
Chapter I.D number for EHGC/HPMC
Chapter I.D Subheading
Kandivli
AAA CA 4769KXM001
V
Kandivli
Mumbai - V
27710000091V Dated: 01/04/06
MUMA18885G
27710000091C Dated: 01/04/06
400036002
AAA CA 4769 K, ACG Lukaps - 95072828169
MUMA18885G
AAACA4769KST-002
IS NOW REPLACED BY VAT
Gelatin Capsules 96 02 00 30
Cellulose Capsules 96 02 00 90
0388063815
12061
96
Gelatin: 96020030, Cellulose: 96020090
Dahanu
AAA CA 4769KXM003
V
Boisar II
Thane - II
-
-
-
-
-
MUMA24518E
AAACA4769KST-004
-
-
-
-
PLN/187/841DPM/4811/Thn
96
Gelatin: 96020030, Cellulose: 96020090
Shirwal
AAA CA 4769KXM002
Shirwal
Satara
Kolhapur
-
-
-
-
-
PNEA01334E
AAACA4769KST-001
-
-
-
-
PLN/391-94/VUM/MVP/4334/95
96
Gelatin: 96020030, Cellulose: 96020090
Pithampur
Not applicable being special economic zone
Not applicable being special economic zone
Not applicable being special economic zone
Not applicable being special economic zone
23519039762 Dated 09/02/2012
BPLA06040G
23519039762 Dated 09/02/2012
-
AAA CA 4769 K
S-BPLA06040G
AAACA4769KSD-007: Pithampur
-
Gelatin Capsules 96 02 00 30
Cellulose Capsules 96 02 00 90
388063815
Pithampur : 39/D-149/ISEZ/2013
96
Gelatin: 96020030 Cellulose : 96020090

Number of Employee in manufacturing facility:

Sr. No. Department Kandivli Dahanu Shirwal ACG Lukaps Pithampur
1 Gelatin Room 28 37 32 27 26
2 Production 48 57 62 35 60
3 Utility 19 30 28 13 23
4 Purchase 1 2 2 6 2
5 Stores 5 5 6 2 6
6 PFD 45 80 159 58 91
7 QA / QC 42 63 73 38 68
8 HR & Admin 6 10 8 7 5
9 Projects 1 3 1 2 1
10 Accounts & Excise 6 5 5 5 7
11 Maintenance 21 29 23 19 27
12 HOC 2 2 2 3 2
13 IT - 1 1 2 1
14 HPMC - 26 - - 15
15 Sales & Marketing - - - 5 -
Total 224 350 402 222 334

Complete facility area in square meter:

 
Total Area of Plot
Total Built Up
Undeveloped
Kandivli
Factory (131) Stores & IT (145) Commercial (130)
4933 1440 895
6071 1114 826
0 326 69
Dahanu
104900.00
17277.35
87622.65
Shirwal
21103.79
9107.39
119964
ACG Lukaps
20519
4899
15620
Pithampur
106793.74
48422.44
70128.62

Department area of manufacturing facility in square meter:

Sr. No. Department Kandivli Dahanu Shirwal ACG Lukaps Pithampur
1 Gelatin Room 259 1350.52 3320.33 265 548.33
2 Production 1638 3593.92 6340.44 1285 701.50
3 Utility & Maintainance 2210 1891.53 7817.12 2830 1046.4
4 Stores 1114 904.64 632.75 581 298.6
5 PFD 1592 3281.21 1571.20 823 1811.97
6 QA / QC 230 377.50 472 130 431.22
7 HR & Admin 86 681.66 1175 135 130.69
8 Sales & Marketing 424 - - 25 -